chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Bursitis, Musculoskeletal pain
Clinical narrative: Information has been received from a registered pharmacist concerning an 84 year old male patient with hypertension and no known drug allergies who on 22-SEP-2010, was vaccinated IM with 0.5 ml dose of PNEUMOVAX 23 (Lot# 667134/0738Z). Concomitant therapy included "blood pressure and pain medications". The registered pharmacist reported that on 22-SEP-2010, the patient experienced excruciating shoulder pain after administration of PNEUMOVAX 23. Lab diagnostics studies were not performed. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Follow-up information has been from the registered pharmacist, concerning this patient, with a history of benign prostatic hyperplasia and pain management, with no illness at the time of vaccination, who on 22-SEP-2010 at 9:35 was vaccinated IM with 0.5 ml first dose of PNEUMOVAX 23 (Lot# 667134/0738Z) into the right arm. Concomitant vaccination on 22-SEP-2010 at 9:31 included the first dose of FLUZONE (Lot # U3575FA) IM into the left arm. On 22-SEP-2010 at 12 pm, the patient cited "unbearable" pain in the right shoulder. The patient went to ER where he was given MEDROL DOSEPAK and PERCOCET for pain. The patient already had shoulder issue and was currently on medications for. After follow up, with the physician, he found that the patient had right flare of bursitis for which he recommended cortisone shot. Subsequently, the patient recovered from the event. The physician stated that the event was unrelated to PNEUMOVAX 23. The physician mentioned that he also disclosed that the patient went home and washed his car. The patient required emergency room/doctor visit. Follow up information has been received from the registered pharmacist concerning the male patient. It was reported that the patient was vaccinated at a pharmacy and was treated with PERCOCET 5/325. No further information is available.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Fluid retention, Hypoaesthesia, Injected limb mobility decreased, Myalgia, Paraesthesia
Clinical narrative: Information has been received from a medical assistant concerning a 42 year old female who on 13-JAN-2011 at 10:00 AM was vaccinated with a dose of PNEUMOVAX 23 (therapy route not reported, lot # 665401/1320Y). On the same day the patient was also vaccinated with a dose of of FLUZONE (therapy route not reported, lot # U3715AA). On 13-JAN-2011 within 3 hours after receiving the PNEUMOVAX 23, the patient had mild muscle pain from her shoulder to her wrist. It was documented that the patient had a large local reaction to the PNEUMOVAX 23. At 7:00 PM that same day, the patient had severe muscle pain from her shoulder to her wrist. The patient had "puffing, tingling and fluid that formed under the skin". The patient had swelling of the entire arm. The patient reported that ALEVE did not work to relieve her symptoms. The symptoms lasted for three days. By the second day the symptoms went from severe to mild. By day five the patient was back to normal and had recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Swelling, Tenderness
Clinical narrative: Information has been received from a medical assistant concerning a 42 year old female who on 13-JAN-2011 at 10:00 AM was vaccinated with a dose of PNEUMOVAX 23 (therapy route not reported, lot # 665401/1320Y). On the same day the patient was also vaccinated with a dose of of FLUZONE (therapy route not reported, lot # U3715AA). On 13-JAN-2011 within 3 hours after receiving the PNEUMOVAX 23, the patient had mild muscle pain from her shoulder to her wrist. It was documented that the patient had a large local reaction to the PNEUMOVAX 23. At 7:00 PM that same day, the patient had severe muscle pain from her shoulder to her wrist. The patient had "puffing, tingling and fluid that formed under the skin". The patient had swelling of the entire arm. The patient reported that ALEVE did not work to relieve her symptoms. The symptoms lasted for three days. By the second day the symptoms went from severe to mild. By day five the patient was back to normal and had recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Fluid retention, Local reaction, Myalgia, Oedema peripheral, Paraesthesia
Clinical narrative: Information has been received from a medical assistant concerning a 42 year old female who on 13-JAN-2011 at 10:00 AM was vaccinated with a dose of PNEUMOVAX 23 (therapy route not reported, lot # 665401/1320Y). On the same day the patient was also vaccinated with a dose of of FLUZONE (therapy route not reported, lot # U3715AA). On 13-JAN-2011 within 3 hours after receiving the PNEUMOVAX 23, the patient had mild muscle pain from her shoulder to her wrist. It was documented that the patient had a large local reaction to the PNEUMOVAX 23. At 7:00 PM that same day, the patient had severe muscle pain from her shoulder to her wrist. The patient had "puffing, tingling and fluid that formed under the skin". The patient had swelling of the entire arm. The patient reported that ALEVE did not work to relieve her symptoms. The symptoms lasted for three days. By the second day the symptoms went from severe to mild. By day five the patient was back to normal and had recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Swelling
Clinical narrative: Information has been received from a medical assistant concerning a 42 year old female who on 13-JAN-2011 at 10:00 AM was vaccinated with a dose of PNEUMOVAX 23 (therapy route not reported, lot # 665401/1320Y). On the same day the patient was also vaccinated with a dose of of FLUZONE (therapy route not reported, lot # U3715AA). On 13-JAN-2011 within 3 hours after receiving the PNEUMOVAX 23, the patient had mild muscle pain from her shoulder to her wrist. It was documented that the patient had a large local reaction to the PNEUMOVAX 23. At 7:00 PM that same day, the patient had severe muscle pain from her shoulder to her wrist. The patient had "puffing, tingling and fluid that formed under the skin". The patient had swelling of the entire arm. The patient reported that ALEVE did not work to relieve her symptoms. The symptoms lasted for three days. By the second day the symptoms went from severe to mild. By day five the patient was back to normal and had recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Local reaction, Mobility decreased, Pain in extremity, Pain of skin
Clinical narrative: Information has been received from a nurse practitioner concerning a "29 year old" female who on 14-JAN-2011 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (therapy route not provided, lot # 665401/1320Y, expired date unspecified). On 14-JAN-2011 the patient experienced "soreness in the arm with the injection site for PNEUMOVAX 23. Patient also reported being unable to raise the arm for up to 2 days following vaccination. Patient sought unspecified medical attention. "Patient could not raise arm for up to 2 days following vaccination" is considered to be disabling by the reporter. This is one of several reports received from the same source. Follow up information was received from the medical assistant who reported that she did not remember the patient's name and could not give any additional information or any other specific patient information other than the patient had recovered. Follow up information was received from the medical assistant who reported that the patient was 29 year old with asthma. The physician had prescribed the patient PNEUMOVAX due to the patient's "medical history of asthma". The medical assistant reported that on 14-JAN-2011 the patient developed a fever and her arm was tender to touch. The patient recovered from all her symptoms approximately on 16-JAN-2011. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a "29 year old" female who on 14-JAN-2011 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (therapy route not provided, lot # 665401/1320Y, expired date unspecified). On 14-JAN-2011 the patient experienced "soreness in the arm with the injection site for PNEUMOVAX 23. Patient also reported being unable to raise the arm for up to 2 days following vaccination. Patient sought unspecified medical attention. "Patient could not raise arm for up to 2 days following vaccination" is considered to be disabling by the reporter. This is one of several reports received from the same source. Follow up information was received from the medical assistant who reported that she did not remember the patient's name and could not give any additional information or any other specific patient information other than the patient had recovered. Follow up information was received from the medical assistant who reported that the patient was 29 year old with asthma. The physician had prescribed the patient PNEUMOVAX due to the patient's "medical history of asthma". The medical assistant reported that on 14-JAN-2011 the patient developed a fever and her arm was tender to touch. The patient recovered from all her symptoms approximately on 16-JAN-2011. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pyrexia, Tenderness
Clinical narrative: Information has been received from a nurse practitioner concerning a "29 year old" female who on 14-JAN-2011 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (therapy route not provided, lot # 665401/1320Y, expired date unspecified). On 14-JAN-2011 the patient experienced "soreness in the arm with the injection site for PNEUMOVAX 23. Patient also reported being unable to raise the arm for up to 2 days following vaccination. Patient sought unspecified medical attention. "Patient could not raise arm for up to 2 days following vaccination" is considered to be disabling by the reporter. This is one of several reports received from the same source. Follow up information was received from the medical assistant who reported that she did not remember the patient's name and could not give any additional information or any other specific patient information other than the patient had recovered. Follow up information was received from the medical assistant who reported that the patient was 29 year old with asthma. The physician had prescribed the patient PNEUMOVAX due to the patient's "medical history of asthma". The medical assistant reported that on 14-JAN-2011 the patient developed a fever and her arm was tender to touch. The patient recovered from all her symptoms approximately on 16-JAN-2011. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: IPV, PPV, TYP, PPV
Symptoms: Injection site erythema, Nausea, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 79 year old female with Asthma and drug/allergy reaction to Rosemary oil and shellfish, who on 24-JAN-2011 was vaccinated with a dose of PNEUMOVAX 23 vaccine (dose, route and lot# unspecified). Concomitant therapy included "birth control pills" (manufacturer unspecified), PROVENTIL, SYMBICORT and ZYRTEC. Physician reported that on 26-JAN-2011, the patient experienced "cellulitis like" injection-site reaction and fever of 103F. The physician stated that the patient was exhibiting signs of bacterial infection at the site, with progressive swelling and patches of blotchy redness. No lab diagnostics studies were performed. No treatment was given "yet" to the patient for the adverse events. At the time of the report patient had not recovered from the events. Patient sought for unspecified medical attention. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: IPV, PPV, TYP, PPV
Symptoms: Skin warm, Tenderness
Clinical narrative: Information has been received from a physician concerning a 79 year old female with Asthma and drug/allergy reaction to Rosemary oil and shellfish, who on 24-JAN-2011 was vaccinated with a dose of PNEUMOVAX 23 vaccine (dose, route and lot# unspecified). Concomitant therapy included "birth control pills" (manufacturer unspecified), PROVENTIL, SYMBICORT and ZYRTEC. Physician reported that on 26-JAN-2011, the patient experienced "cellulitis like" injection-site reaction and fever of 103F. The physician stated that the patient was exhibiting signs of bacterial infection at the site, with progressive swelling and patches of blotchy redness. No lab diagnostics studies were performed. No treatment was given "yet" to the patient for the adverse events. At the time of the report patient had not recovered from the events. Patient sought for unspecified medical attention. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: IPV, PPV, TYP, PPV
Symptoms: Bacterial infection, Injection site erythema, Injection site reaction, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 79 year old female with Asthma and drug/allergy reaction to Rosemary oil and shellfish, who on 24-JAN-2011 was vaccinated with a dose of PNEUMOVAX 23 vaccine (dose, route and lot# unspecified). Concomitant therapy included "birth control pills" (manufacturer unspecified), PROVENTIL, SYMBICORT and ZYRTEC. Physician reported that on 26-JAN-2011, the patient experienced "cellulitis like" injection-site reaction and fever of 103F. The physician stated that the patient was exhibiting signs of bacterial infection at the site, with progressive swelling and patches of blotchy redness. No lab diagnostics studies were performed. No treatment was given "yet" to the patient for the adverse events. At the time of the report patient had not recovered from the events. Patient sought for unspecified medical attention. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: IPV, PPV, TYP, PPV
Symptoms: Rash macular
Clinical narrative: Information has been received from a physician concerning a 79 year old female with Asthma and drug/allergy reaction to Rosemary oil and shellfish, who on 24-JAN-2011 was vaccinated with a dose of PNEUMOVAX 23 vaccine (dose, route and lot# unspecified). Concomitant therapy included "birth control pills" (manufacturer unspecified), PROVENTIL, SYMBICORT and ZYRTEC. Physician reported that on 26-JAN-2011, the patient experienced "cellulitis like" injection-site reaction and fever of 103F. The physician stated that the patient was exhibiting signs of bacterial infection at the site, with progressive swelling and patches of blotchy redness. No lab diagnostics studies were performed. No treatment was given "yet" to the patient for the adverse events. At the time of the report patient had not recovered from the events. Patient sought for unspecified medical attention. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Lymphadenopathy, Pyrexia
Clinical narrative: Information has been received from a Certified Medical Assistant (C.M.A.) concerning a 39 year old male with hypertension and cardiovascular disease and with no drug reactions/allergies who on 12-OCT-2010 was vaccinated intramuscularly with a 0.5mL dose of PNEUMOVAX 23 (lot#665903/1427Y; 30-JUL-2011) in his right deltoid. Secondary therapy included FLULAVAL. Concomitant therapy included lisinopril (manufacturer unknown), COREG and metoprolol. On 12-OCT-2010, 3 hours post administration the patient presented with a fever of 103 and his lymph nodes were swollen. Patient complained of pain at injection site. The patient was seen at physician's office on 13-OCT-2010 and injection site presented with edema and possible cellulitis. The area was hot to touch. Physician prescribed AUGMENTIN. Medical assistant stated they had not spoken to the patient on 14-OCT-2010 (reported as "today"). Medical assistant also mentioned that the patient was administered FLULAVAL concomitantly at the same injection site. At the time of the report, the outcomes were unknown. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site oedema, Injection site pain, Injection site warmth, Lymphadenopathy, Pyrexia
Clinical narrative: Information has been received from a Certified Medical Assistant (C.M.A.) concerning a 39 year old male with hypertension and cardiovascular disease and with no drug reactions/allergies who on 12-OCT-2010 was vaccinated intramuscularly with a 0.5mL dose of PNEUMOVAX 23 (lot#665903/1427Y; 30-JUL-2011) in his right deltoid. Secondary therapy included FLULAVAL. Concomitant therapy included lisinopril (manufacturer unknown), COREG and metoprolol. On 12-OCT-2010, 3 hours post administration the patient presented with a fever of 103 and his lymph nodes were swollen. Patient complained of pain at injection site. The patient was seen at physician's office on 13-OCT-2010 and injection site presented with edema and possible cellulitis. The area was hot to touch. Physician prescribed AUGMENTIN. Medical assistant stated they had not spoken to the patient on 14-OCT-2010 (reported as "today"). Medical assistant also mentioned that the patient was administered FLULAVAL concomitantly at the same injection site. At the time of the report, the outcomes were unknown. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, White blood cell count increased
Clinical narrative: Information has been received from a nurse concerning a 33 year old female with seasonal allergy and asthma who on 15-FEB-2011 was vaccinated with PNEUMOVAX 23 0.5ml subcutaneous in right arm (lot#667913/1021Z). Concomitant therapy included FLONASE, ADVAIR discus, PROAIR, ZYRTEC and "OTC Decongestant". On 16-FEB-2011 the patient developed cellulitis like reaction of right arm. The patient went to the local ER, unspecified name, on 17-Feb-2011 and was treated with NORCO and was released; not hospitalized. On an unspecified date, the nurse stated patient went back again to the ER, and was prescribed antibiotics, and was not hospitalized. Nurse states that the doctor had follow up call with patient and the patient states she was doing better. Follow up information has been received from a physician concerning the female with rhinitis allergies who on 15-FEB-2011 14 o'clock was vaccinated with the first dose of PNEUMOVAX 23 in the right deltoid of right arm. On 15-FEB-2011 16 o'clock, the patient developed cellulitis like reaction (also reported as "cellulitis like reaction developed over 24-96 hours post injection"), redness, swelling, fever and nausea. The white blood cell scan revealed positive. Vaccine was tested, and revealed negative for bacterial contamination. At the time of the report, the patient had recovered. No further information is available.
Age: 33.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling, Nausea, Pyrexia, White blood cell count increased
Clinical narrative: Information has been received from a nurse concerning a 33 year old female with seasonal allergy and asthma who on 15-FEB-2011 was vaccinated with PNEUMOVAX 23 0.5ml subcutaneous in right arm (lot#667913/1021Z). Concomitant therapy included FLONASE, ADVAIR discus, PROAIR, ZYRTEC and "OTC Decongestant". On 16-FEB-2011 the patient developed cellulitis like reaction of right arm. The patient went to the local ER, unspecified name, on 17-Feb-2011 and was treated with NORCO and was released; not hospitalized. On an unspecified date, the nurse stated patient went back again to the ER, and was prescribed antibiotics, and was not hospitalized. Nurse states that the doctor had follow up call with patient and the patient states she was doing better. Follow up information has been received from a physician concerning the female with rhinitis allergies who on 15-FEB-2011 14 o'clock was vaccinated with the first dose of PNEUMOVAX 23 in the right deltoid of right arm. On 15-FEB-2011 16 o'clock, the patient developed cellulitis like reaction (also reported as "cellulitis like reaction developed over 24-96 hours post injection"), redness, swelling, fever and nausea. The white blood cell scan revealed positive. Vaccine was tested, and revealed negative for bacterial contamination. At the time of the report, the patient had recovered. No further information is available.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Influenza like illness, Injection site pain, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a 66 year old female consumer who on 25-FEB-2011 was vaccinated with a 0.5ml dose of PNEUMOVAX 23. The patient reported that on 25-FEB-2011 she experienced right arm injection "site" swelling and pain. No treatment was given for the adverse event. The patient did not seek medical attention. It was unspecified if lab diagnostic studies were performed. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a 66 year old female consumer who on 25-FEB-2011 was vaccinated with a 0.5ml dose of PNEUMOVAX 23. The patient reported that on 25-FEB-2011 she experienced right arm injection "site" swelling and pain. No treatment was given for the adverse event. The patient did not seek medical attention. It was unspecified if lab diagnostic studies were performed. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a 66 year old female consumer who on 25-FEB-2011 was vaccinated with a 0.5ml dose of PNEUMOVAX 23. The patient reported that on 25-FEB-2011 she experienced right arm injection "site" swelling and pain. No treatment was given for the adverse event. The patient did not seek medical attention. It was unspecified if lab diagnostic studies were performed. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Local reaction, Pyrexia
Clinical narrative: Information has been received from a 51 year old female consumer with asthma and thyroid disorder, with no drug reactions or allergies who on 22-FEB-2011 was vaccinated with a dose of PNEUMOVAX 23 (lot number 667916/1066Z). Concomitant therapy included FLUVIRIN, levothyroxine Na and VENTAL inhaler. Patient reported that after receiving PNEUMOVAX 23 on 22-FEB-2011, on 23-FEB-2011 (reported as "next day"), she started experiencing a temperature of 102. She was hot and cold, her arm swelled up and was very red. On the 24th, 24-FEB-2011, the patient vomited; and she was sent for a chest X-ray (result not provided). During the day, the temperature was low, and at night it was high. The doctor confirmed by looking at her, that it was a reaction to the vaccine. Her lymph nodes were inflamed. The patient was not given anything for it, and it slowly went away. The worst thing was that it caused her immune system to struggle and the patient broke out in cold sores all over her face, some up to two inches in diameter. The patient also received FLUVIRIN at the same time. However, it was in the other arm that did not give a reaction. It was definitely the arm from the PNEUMOVAX 23. After 3 or 4 days, the redness had gone from the arm and things started to get better". The patient was recovering. No laboratories were performed. Follow up information was received from a certified medical assistant, concerning a 51 year old female patient with asthma/acute exacerbation at the time of vaccination and no known drug allergies who on 22-FEB-2011 at 16:30 was vaccinated on the bottom of the right deltoid with a first dose of PNEUMOVAX 23 (lot number 67916/1066Z). Suspect secondary therapy included first dose of FLUVIRIN (lot # 11294501) administered on the same date in the right deltoid (TCP). Concomitant therapy included QVAR, levothyroxine Na 125 mg and albuterol solution/nebulizer. The certified medical assistant reported that the patient on 23-FEB-2011 had cellulitis, fever and local reaction at deltoid and a temperature of 102 and on an unknown date the patient had recovered. No further information is available.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Chest X-ray, Erythema, Feeling of body temperature change, Immune system disorder
Clinical narrative: Information has been received from a 51 year old female consumer with asthma and thyroid disorder, with no drug reactions or allergies who on 22-FEB-2011 was vaccinated with a dose of PNEUMOVAX 23 (lot number 667916/1066Z). Concomitant therapy included FLUVIRIN, levothyroxine Na and VENTAL inhaler. Patient reported that after receiving PNEUMOVAX 23 on 22-FEB-2011, on 23-FEB-2011 (reported as "next day"), she started experiencing a temperature of 102. She was hot and cold, her arm swelled up and was very red. On the 24th, 24-FEB-2011, the patient vomited; and she was sent for a chest X-ray (result not provided). During the day, the temperature was low, and at night it was high. The doctor confirmed by looking at her, that it was a reaction to the vaccine. Her lymph nodes were inflamed. The patient was not given anything for it, and it slowly went away. The worst thing was that it caused her immune system to struggle and the patient broke out in cold sores all over her face, some up to two inches in diameter. The patient also received FLUVIRIN at the same time. However, it was in the other arm that did not give a reaction. It was definitely the arm from the PNEUMOVAX 23. After 3 or 4 days, the redness had gone from the arm and things started to get better". The patient was recovering. No laboratories were performed. Follow up information was received from a certified medical assistant, concerning a 51 year old female patient with asthma/acute exacerbation at the time of vaccination and no known drug allergies who on 22-FEB-2011 at 16:30 was vaccinated on the bottom of the right deltoid with a first dose of PNEUMOVAX 23 (lot number 67916/1066Z). Suspect secondary therapy included first dose of FLUVIRIN (lot # 11294501) administered on the same date in the right deltoid (TCP). Concomitant therapy included QVAR, levothyroxine Na 125 mg and albuterol solution/nebulizer. The certified medical assistant reported that the patient on 23-FEB-2011 had cellulitis, fever and local reaction at deltoid and a temperature of 102 and on an unknown date the patient had recovered. No further information is available.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Local reaction, Lymphadenopathy, Oedema peripheral, Oral herpes, Pyrexia
Clinical narrative: Information has been received from a 51 year old female consumer with asthma and thyroid disorder, with no drug reactions or allergies who on 22-FEB-2011 was vaccinated with a dose of PNEUMOVAX 23 (lot number 667916/1066Z). Concomitant therapy included FLUVIRIN, levothyroxine Na and VENTAL inhaler. Patient reported that after receiving PNEUMOVAX 23 on 22-FEB-2011, on 23-FEB-2011 (reported as "next day"), she started experiencing a temperature of 102. She was hot and cold, her arm swelled up and was very red. On the 24th, 24-FEB-2011, the patient vomited; and she was sent for a chest X-ray (result not provided). During the day, the temperature was low, and at night it was high. The doctor confirmed by looking at her, that it was a reaction to the vaccine. Her lymph nodes were inflamed. The patient was not given anything for it, and it slowly went away. The worst thing was that it caused her immune system to struggle and the patient broke out in cold sores all over her face, some up to two inches in diameter. The patient also received FLUVIRIN at the same time. However, it was in the other arm that did not give a reaction. It was definitely the arm from the PNEUMOVAX 23. After 3 or 4 days, the redness had gone from the arm and things started to get better". The patient was recovering. No laboratories were performed. Follow up information was received from a certified medical assistant, concerning a 51 year old female patient with asthma/acute exacerbation at the time of vaccination and no known drug allergies who on 22-FEB-2011 at 16:30 was vaccinated on the bottom of the right deltoid with a first dose of PNEUMOVAX 23 (lot number 67916/1066Z). Suspect secondary therapy included first dose of FLUVIRIN (lot # 11294501) administered on the same date in the right deltoid (TCP). Concomitant therapy included QVAR, levothyroxine Na 125 mg and albuterol solution/nebulizer. The certified medical assistant reported that the patient on 23-FEB-2011 had cellulitis, fever and local reaction at deltoid and a temperature of 102 and on an unknown date the patient had recovered. No further information is available.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Vomiting
Clinical narrative: Information has been received from a 51 year old female consumer with asthma and thyroid disorder, with no drug reactions or allergies who on 22-FEB-2011 was vaccinated with a dose of PNEUMOVAX 23 (lot number 667916/1066Z). Concomitant therapy included FLUVIRIN, levothyroxine Na and VENTAL inhaler. Patient reported that after receiving PNEUMOVAX 23 on 22-FEB-2011, on 23-FEB-2011 (reported as "next day"), she started experiencing a temperature of 102. She was hot and cold, her arm swelled up and was very red. On the 24th, 24-FEB-2011, the patient vomited; and she was sent for a chest X-ray (result not provided). During the day, the temperature was low, and at night it was high. The doctor confirmed by looking at her, that it was a reaction to the vaccine. Her lymph nodes were inflamed. The patient was not given anything for it, and it slowly went away. The worst thing was that it caused her immune system to struggle and the patient broke out in cold sores all over her face, some up to two inches in diameter. The patient also received FLUVIRIN at the same time. However, it was in the other arm that did not give a reaction. It was definitely the arm from the PNEUMOVAX 23. After 3 or 4 days, the redness had gone from the arm and things started to get better". The patient was recovering. No laboratories were performed. Follow up information was received from a certified medical assistant, concerning a 51 year old female patient with asthma/acute exacerbation at the time of vaccination and no known drug allergies who on 22-FEB-2011 at 16:30 was vaccinated on the bottom of the right deltoid with a first dose of PNEUMOVAX 23 (lot number 67916/1066Z). Suspect secondary therapy included first dose of FLUVIRIN (lot # 11294501) administered on the same date in the right deltoid (TCP). Concomitant therapy included QVAR, levothyroxine Na 125 mg and albuterol solution/nebulizer. The certified medical assistant reported that the patient on 23-FEB-2011 had cellulitis, fever and local reaction at deltoid and a temperature of 102 and on an unknown date the patient had recovered. No further information is available.
Age: 81.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Arthralgia, Muscular weakness, Neck pain, Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning a female patient with "A lot of allergies to a lot of things" who on 07-JAN-2011 was vaccinated with a dose of PNEUMOVAX 23 (Lot#665401/1320Y, Exp date 20-MAY-2011, route and dose not reported). There was no concomitant medication. Pharmacist started that on 08-JAN-2011 the patient experienced stiff neck and pain in the neck. At the time of the report the patient's outcome was unknown. The patient contacted the pharmacist via phone call. Follow-up information has been received from the registered pharmacist who reported that the now 81 year old female patient with penicillin, sulfa, amlodipine, OCUFLOX, lidocaine, glycerin, aloe, ginseng, glipizide, "rich pine", CIPRO, PROLOPRIM, ACLOR, CLEOCIN and tamoxifen allergies was vaccinated with a second dose of PNEUMOVAX 23 (Lot#665401/1320Y, Exp date 20-MAY-2011, route and dose not reported), on 07-JAN-2011, Unknown time. Pharmacist stated that on 08-JAN-2011 the patient experienced very painful stiff neck and the patient was still experiencing some effects a month later when she called pharmacy to ask if any side effect could be associate to PNEUMOVAX 23. The patient had similar effect following lidocaine injection. At the time of the report the patient's outcome was unknown. Follow-up information has been received from a female consumer reporting on herself, with allergies to "lots of unspecified medications" and a history of breast cancer, gallbladder surgery and pneumonia who on 07-JAN-2011 was intramuscularly vaccinated with 0.5mL of PNEUMOVAX 23 (Lot#665401/1320Y, Exp date 20-MAY-2011). There was no concomitant medication. Female consumer reported that still she was experiencing muscle stiffness, specifically in her neck. She said her hands hurt and she had a difficult time grasping or grapping things. Unspecified annual check-ups labs were reported. No treatment for this adverse event was performed. It was reported that the consumer did not seek medical attention. At the time of reporting consumer was not recovered. Additional information is expected.
Age: 81.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Arthralgia, Muscular weakness, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning a female patient with "A lot of allergies to a lot of things" who on 07-JAN-2011 was vaccinated with a dose of PNEUMOVAX 23 (Lot#665401/1320Y, Exp date 20-MAY-2011, route and dose not reported). There was no concomitant medication. Pharmacist started that on 08-JAN-2011 the patient experienced stiff neck and pain in the neck. At the time of the report the patient's outcome was unknown. The patient contacted the pharmacist via phone call. Follow-up information has been received from the registered pharmacist who reported that the now 81 year old female patient with penicillin, sulfa, amlodipine, OCUFLOX, lidocaine, glycerin, aloe, ginseng, glipizide, "rich pine", CIPRO, PROLOPRIM, ACLOR, CLEOCIN and tamoxifen allergies was vaccinated with a second dose of PNEUMOVAX 23 (Lot#665401/1320Y, Exp date 20-MAY-2011, route and dose not reported), on 07-JAN-2011, Unknown time. Pharmacist stated that on 08-JAN-2011 the patient experienced very painful stiff neck and the patient was still experiencing some effects a month later when she called pharmacy to ask if any side effect could be associate to PNEUMOVAX 23. The patient had similar effect following lidocaine injection. At the time of the report the patient's outcome was unknown. Follow-up information has been received from a female consumer reporting on herself, with allergies to "lots of unspecified medications" and a history of breast cancer, gallbladder surgery and pneumonia who on 07-JAN-2011 was intramuscularly vaccinated with 0.5mL of PNEUMOVAX 23 (Lot#665401/1320Y, Exp date 20-MAY-2011). There was no concomitant medication. Female consumer reported that still she was experiencing muscle stiffness, specifically in her neck. She said her hands hurt and she had a difficult time grasping or grapping things. Unspecified annual check-ups labs were reported. No treatment for this adverse event was performed. It was reported that the consumer did not seek medical attention. At the time of reporting consumer was not recovered. Additional information is expected.
Age: 81.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Grip strength decreased, Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning a female patient with "A lot of allergies to a lot of things" who on 07-JAN-2011 was vaccinated with a dose of PNEUMOVAX 23 (Lot#665401/1320Y, Exp date 20-MAY-2011, route and dose not reported). There was no concomitant medication. Pharmacist started that on 08-JAN-2011 the patient experienced stiff neck and pain in the neck. At the time of the report the patient's outcome was unknown. The patient contacted the pharmacist via phone call. Follow-up information has been received from the registered pharmacist who reported that the now 81 year old female patient with penicillin, sulfa, amlodipine, OCUFLOX, lidocaine, glycerin, aloe, ginseng, glipizide, "rich pine", CIPRO, PROLOPRIM, ACLOR, CLEOCIN and tamoxifen allergies was vaccinated with a second dose of PNEUMOVAX 23 (Lot#665401/1320Y, Exp date 20-MAY-2011, route and dose not reported), on 07-JAN-2011, Unknown time. Pharmacist stated that on 08-JAN-2011 the patient experienced very painful stiff neck and the patient was still experiencing some effects a month later when she called pharmacy to ask if any side effect could be associate to PNEUMOVAX 23. The patient had similar effect following lidocaine injection. At the time of the report the patient's outcome was unknown. Follow-up information has been received from a female consumer reporting on herself, with allergies to "lots of unspecified medications" and a history of breast cancer, gallbladder surgery and pneumonia who on 07-JAN-2011 was intramuscularly vaccinated with 0.5mL of PNEUMOVAX 23 (Lot#665401/1320Y, Exp date 20-MAY-2011). There was no concomitant medication. Female consumer reported that still she was experiencing muscle stiffness, specifically in her neck. She said her hands hurt and she had a difficult time grasping or grapping things. Unspecified annual check-ups labs were reported. No treatment for this adverse event was performed. It was reported that the consumer did not seek medical attention. At the time of reporting consumer was not recovered. Additional information is expected.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Blood test, Erythema, Mass, Pain
Clinical narrative: Information has been received from a medical assistant concerning a 70 year old female patient who on 11-MAR-2011 was vaccinated IM with a 0.5ml dose of PNEUMOVAX 23 (667690/1158Z, exp: 26-JAN-2012). On 12-MAR-2011 the patient experienced left arm swelling near the injection site, with swelling and redness. The healthcare worker reported that the patient was diagnosed with cellulitis of left arm. At the time of reporting, the patient was recovering. The patient saw infectious disease specialist to seek medical attention. The physician requested a lot check. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow-up information has been received from the medical assistant indicating that the female patient with no illness at time of vaccination and no known pre-existing allergies, birth defects, medical conditions was intramuscularly vaccinated with the first dose of PNEUMOVAX 23 (lot# 667690/1158Z) into her left deltoid on 11-MAR-2011. The patient experienced acute swelling and redness near vaccine administered site the next day. Eventually the patient was placed on antibiotics by day 2, day 4 antibiotics were expanded. On 14-MAR-2011, the white blood cell count (WBC) was 12.4, serum C-reactive protein (CRP) was 7.7, and erythrocyte sedimentation rate (ESR) was 13. On 16-MAR-2011, the white blood cell count (WBC) was 7.3, serum C-reactive protein (CRP) was 5.8, and erythrocyte sedimentation rate (ESR) was 26. It was unclear if the adverse event was allergic or infections. Cellulitis of left arm was considered to be disabling by the reporter. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: C-reactive protein increased, Cellulitis, Injection site erythema, Injection site swelling, Red blood cell sedimentation rate increased
Clinical narrative: Information has been received from a medical assistant concerning a 70 year old female patient who on 11-MAR-2011 was vaccinated IM with a 0.5ml dose of PNEUMOVAX 23 (667690/1158Z, exp: 26-JAN-2012). On 12-MAR-2011 the patient experienced left arm swelling near the injection site, with swelling and redness. The healthcare worker reported that the patient was diagnosed with cellulitis of left arm. At the time of reporting, the patient was recovering. The patient saw infectious disease specialist to seek medical attention. The physician requested a lot check. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow-up information has been received from the medical assistant indicating that the female patient with no illness at time of vaccination and no known pre-existing allergies, birth defects, medical conditions was intramuscularly vaccinated with the first dose of PNEUMOVAX 23 (lot# 667690/1158Z) into her left deltoid on 11-MAR-2011. The patient experienced acute swelling and redness near vaccine administered site the next day. Eventually the patient was placed on antibiotics by day 2, day 4 antibiotics were expanded. On 14-MAR-2011, the white blood cell count (WBC) was 12.4, serum C-reactive protein (CRP) was 7.7, and erythrocyte sedimentation rate (ESR) was 13. On 16-MAR-2011, the white blood cell count (WBC) was 7.3, serum C-reactive protein (CRP) was 5.8, and erythrocyte sedimentation rate (ESR) was 26. It was unclear if the adverse event was allergic or infections. Cellulitis of left arm was considered to be disabling by the reporter. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: White blood cell count increased
Clinical narrative: Information has been received from a medical assistant concerning a 70 year old female patient who on 11-MAR-2011 was vaccinated IM with a 0.5ml dose of PNEUMOVAX 23 (667690/1158Z, exp: 26-JAN-2012). On 12-MAR-2011 the patient experienced left arm swelling near the injection site, with swelling and redness. The healthcare worker reported that the patient was diagnosed with cellulitis of left arm. At the time of reporting, the patient was recovering. The patient saw infectious disease specialist to seek medical attention. The physician requested a lot check. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow-up information has been received from the medical assistant indicating that the female patient with no illness at time of vaccination and no known pre-existing allergies, birth defects, medical conditions was intramuscularly vaccinated with the first dose of PNEUMOVAX 23 (lot# 667690/1158Z) into her left deltoid on 11-MAR-2011. The patient experienced acute swelling and redness near vaccine administered site the next day. Eventually the patient was placed on antibiotics by day 2, day 4 antibiotics were expanded. On 14-MAR-2011, the white blood cell count (WBC) was 12.4, serum C-reactive protein (CRP) was 7.7, and erythrocyte sedimentation rate (ESR) was 13. On 16-MAR-2011, the white blood cell count (WBC) was 7.3, serum C-reactive protein (CRP) was 5.8, and erythrocyte sedimentation rate (ESR) was 26. It was unclear if the adverse event was allergic or infections. Cellulitis of left arm was considered to be disabling by the reporter. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hypoaesthesia, Injection site erythema, Injection site swelling, Oedema peripheral
Clinical narrative: Information has been received from a registered nurse concerning a 61 year old female patient, who on 30-OCT-2000 was vaccinated with her first dose of PNEUMOVAX 23 (lot # not reported) (Dose and route not reported). The nurse reported that the patient (who is also a nurse), on 06-JAN-2011, was vaccinated with her second dose of PNEUMOVAX 23 (lot # 664871/1142Y, exp: 30-MAR-2011) (dose and route not reported) and experienced soreness and stiffness, swelling in the deltoid muscles extending to the axillary and redness at the injection site. It was unspecified if the patient sought medical attention. At the time of the report, the patient's outcome was unknown. Follow-up information has been received from the registered nurse, concerning a 51 (previously reported as 61) year old, female patient, with a history of scoliosis, arthritis, pulmonary embolism, cataracts, "asthmatic condition", redness and swelling on approximately 1989, "in 30's", several times, with influenza virus vaccine (unspecified) and tetanus toxoid vaccine" and with allergy to erythromycin and a couple of unspecified pain medications, who on 06-JAN-2011 at 15:30 received intramuscularly in the left deltoid, her second dose of PNEUMOVAX 23 (Lot #: 664871/1142Y, exp: 30-MAR-2011) (dose not reported). Registered nurse reported that on 12-JAN-2011, approximately 6-7 days after vaccination, (previously reported as 06-JAN-2011 by the same reporter), "redness and swelling occurred to deltoid and lasted couple days". Registered nurse reported that "swelling occurred to left axillary and arm would feel numb in certain positions". She stated that this occurred frequently until mid-March (approximately on 15-MAR-2011). At the time of the report, patient had recovered from the "redness, swelling and numb in certain positions. No further information is available.
Age: 51.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hypoaesthesia, Injection site erythema, Musculoskeletal stiffness, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 61 year old female patient, who on 30-OCT-2000 was vaccinated with her first dose of PNEUMOVAX 23 (lot # not reported) (Dose and route not reported). The nurse reported that the patient (who is also a nurse), on 06-JAN-2011, was vaccinated with her second dose of PNEUMOVAX 23 (lot # 664871/1142Y, exp: 30-MAR-2011) (dose and route not reported) and experienced soreness and stiffness, swelling in the deltoid muscles extending to the axillary and redness at the injection site. It was unspecified if the patient sought medical attention. At the time of the report, the patient's outcome was unknown. Follow-up information has been received from the registered nurse, concerning a 51 (previously reported as 61) year old, female patient, with a history of scoliosis, arthritis, pulmonary embolism, cataracts, "asthmatic condition", redness and swelling on approximately 1989, "in 30's", several times, with influenza virus vaccine (unspecified) and tetanus toxoid vaccine" and with allergy to erythromycin and a couple of unspecified pain medications, who on 06-JAN-2011 at 15:30 received intramuscularly in the left deltoid, her second dose of PNEUMOVAX 23 (Lot #: 664871/1142Y, exp: 30-MAR-2011) (dose not reported). Registered nurse reported that on 12-JAN-2011, approximately 6-7 days after vaccination, (previously reported as 06-JAN-2011 by the same reporter), "redness and swelling occurred to deltoid and lasted couple days". Registered nurse reported that "swelling occurred to left axillary and arm would feel numb in certain positions". She stated that this occurred frequently until mid-March (approximately on 15-MAR-2011). At the time of the report, patient had recovered from the "redness, swelling and numb in certain positions. No further information is available.
Age: 50.0
Sex: M
Vaccine: ANTH, ANTH, SMALL, TYP
Symptoms: Arthralgia, Burning sensation, Dysstasia, Fear of falling, Hypoaesthesia
Clinical narrative: 1) Tinnitus - 2 weeks after was first symptom of which I still have. Please refer to attached timeline for complete list of symptoms I attribute to the Anthrax series I received.