chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Headache, Hypokinesia, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a 30 year old male with asthma and no known allergies who on Jan 07 2005, at approximately 10:00am, was vaccinated IM in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 647724/0946N). Concomitant vaccination that day at the same time included a first dose in the left deltoid of influenza virus whole virion 3v vaccine inactivated (Fluzone) (Lot U1531AA). Other concomitant medication included fluticasone propionate (+) salmeterol xinafoate (Advair). zafirlukas (Accolate), ibuprofen, acetaminophen (Tylenol) and azithromycin (Zithromax. Illness at the time of vaccination included a URI and sinusitis, On Jan 09 2005, the patient developed redness, tenderness, swelling and pain in the vaccinated arm, with decreased range of motion, nausea and vomiting. On Jan 10 2004, the patient went to the emergency room, and subsequently, was hospitalized for cellulitis. The patient was treated with ampicillin sodium (+) sulbactam sodium (Unasyn), IV, methylprednisolone sodium succinate (Solu-medrol), IV, and acetaminophen (+) propoxyphene napsylate (Darvocet-N 100) while in the hospital. It was reported that the patient was discharged from the hospital. and subsequently, recovered. Follow up information has been received from a LPN and medical records. The nurse reported redness, swelling and pain at the site of injection along with a severe headache,. the patient went to the ER on Jan 09 2005 and got scripts for po amoxicillin (+) clavulanate potassium (Augmentin) and IM ceftriaxone sodium (Rocephin). Diagnosis was left arm cellulitis, The medical records indicated that on exam, the arm was very red (erythema) and hot (warmth) with swelling and fever. At the visit the patient reported that it hurt to raise or move the arm . Laboratory results from Jan 09 2005 included a WBC of 12.8 with segs of 88% and a sed rate of 35mm/hr. The nurse reported that the redness, pain, swelling and warmth at the site increased. The patient also had decreased ROM and nausea and vomiting developed. The patient was admitted to the hospital on Jan 10 2005 with diagnosis of cellulitis and sinusitis. medical records indicated that the chief complaint at admission included weakness, nausea, vomiting, headache and pain and redness in the left arm. Treatment included IV fluids, IV methylprednisolone sodium succinate (SOLU-MEDROL), IV ampicillin sodium  (+) sulbactam sodium (Unasyn), Iv metoclopramide hydrochloride (Reglan), guaifenesin (+) phenylephrine hydrochloride (+) phenypropanolamine hydrochloride (Entex PSE), acetaminophen (+) propoxyphene napsylate (Darvocet-N), saline spray and amantadine hydrochloride. Influenza AB screen neutrophil count and sed rate were all increased. See laboratory section for all relevant results. It was reported that the patient recovered on Jan 24 2005. Additional information is not expected.
Age: 31.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site swelling, Injection site warmth, Laboratory test abnormal, Medication error, Nausea
Clinical narrative: Information has been received from a licensed practical nurse concerning a 30 year old male with asthma and no known allergies who on Jan 07 2005, at approximately 10:00am, was vaccinated IM in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 647724/0946N). Concomitant vaccination that day at the same time included a first dose in the left deltoid of influenza virus whole virion 3v vaccine inactivated (Fluzone) (Lot U1531AA). Other concomitant medication included fluticasone propionate (+) salmeterol xinafoate (Advair). zafirlukas (Accolate), ibuprofen, acetaminophen (Tylenol) and azithromycin (Zithromax. Illness at the time of vaccination included a URI and sinusitis, On Jan 09 2005, the patient developed redness, tenderness, swelling and pain in the vaccinated arm, with decreased range of motion, nausea and vomiting. On Jan 10 2004, the patient went to the emergency room, and subsequently, was hospitalized for cellulitis. The patient was treated with ampicillin sodium (+) sulbactam sodium (Unasyn), IV, methylprednisolone sodium succinate (Solu-medrol), IV, and acetaminophen (+) propoxyphene napsylate (Darvocet-N 100) while in the hospital. It was reported that the patient was discharged from the hospital. and subsequently, recovered. Follow up information has been received from a LPN and medical records. The nurse reported redness, swelling and pain at the site of injection along with a severe headache,. the patient went to the ER on Jan 09 2005 and got scripts for po amoxicillin (+) clavulanate potassium (Augmentin) and IM ceftriaxone sodium (Rocephin). Diagnosis was left arm cellulitis, The medical records indicated that on exam, the arm was very red (erythema) and hot (warmth) with swelling and fever. At the visit the patient reported that it hurt to raise or move the arm . Laboratory results from Jan 09 2005 included a WBC of 12.8 with segs of 88% and a sed rate of 35mm/hr. The nurse reported that the redness, pain, swelling and warmth at the site increased. The patient also had decreased ROM and nausea and vomiting developed. The patient was admitted to the hospital on Jan 10 2005 with diagnosis of cellulitis and sinusitis. medical records indicated that the chief complaint at admission included weakness, nausea, vomiting, headache and pain and redness in the left arm. Treatment included IV fluids, IV methylprednisolone sodium succinate (SOLU-MEDROL), IV ampicillin sodium  (+) sulbactam sodium (Unasyn), Iv metoclopramide hydrochloride (Reglan), guaifenesin (+) phenylephrine hydrochloride (+) phenypropanolamine hydrochloride (Entex PSE), acetaminophen (+) propoxyphene napsylate (Darvocet-N), saline spray and amantadine hydrochloride. Influenza AB screen neutrophil count and sed rate were all increased. See laboratory section for all relevant results. It was reported that the patient recovered on Jan 24 2005. Additional information is not expected.
Age: 31.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning a 30 year old male with asthma and no known allergies who on Jan 07 2005, at approximately 10:00am, was vaccinated IM in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 647724/0946N). Concomitant vaccination that day at the same time included a first dose in the left deltoid of influenza virus whole virion 3v vaccine inactivated (Fluzone) (Lot U1531AA). Other concomitant medication included fluticasone propionate (+) salmeterol xinafoate (Advair). zafirlukas (Accolate), ibuprofen, acetaminophen (Tylenol) and azithromycin (Zithromax. Illness at the time of vaccination included a URI and sinusitis, On Jan 09 2005, the patient developed redness, tenderness, swelling and pain in the vaccinated arm, with decreased range of motion, nausea and vomiting. On Jan 10 2004, the patient went to the emergency room, and subsequently, was hospitalized for cellulitis. The patient was treated with ampicillin sodium (+) sulbactam sodium (Unasyn), IV, methylprednisolone sodium succinate (Solu-medrol), IV, and acetaminophen (+) propoxyphene napsylate (Darvocet-N 100) while in the hospital. It was reported that the patient was discharged from the hospital. and subsequently, recovered. Follow up information has been received from a LPN and medical records. The nurse reported redness, swelling and pain at the site of injection along with a severe headache,. the patient went to the ER on Jan 09 2005 and got scripts for po amoxicillin (+) clavulanate potassium (Augmentin) and IM ceftriaxone sodium (Rocephin). Diagnosis was left arm cellulitis, The medical records indicated that on exam, the arm was very red (erythema) and hot (warmth) with swelling and fever. At the visit the patient reported that it hurt to raise or move the arm . Laboratory results from Jan 09 2005 included a WBC of 12.8 with segs of 88% and a sed rate of 35mm/hr. The nurse reported that the redness, pain, swelling and warmth at the site increased. The patient also had decreased ROM and nausea and vomiting developed. The patient was admitted to the hospital on Jan 10 2005 with diagnosis of cellulitis and sinusitis. medical records indicated that the chief complaint at admission included weakness, nausea, vomiting, headache and pain and redness in the left arm. Treatment included IV fluids, IV methylprednisolone sodium succinate (SOLU-MEDROL), IV ampicillin sodium  (+) sulbactam sodium (Unasyn), Iv metoclopramide hydrochloride (Reglan), guaifenesin (+) phenylephrine hydrochloride (+) phenypropanolamine hydrochloride (Entex PSE), acetaminophen (+) propoxyphene napsylate (Darvocet-N), saline spray and amantadine hydrochloride. Influenza AB screen neutrophil count and sed rate were all increased. See laboratory section for all relevant results. It was reported that the patient recovered on Jan 24 2005. Additional information is not expected.
Age: 31.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Asthenia, Blood cholesterol increased, Cellulitis
Clinical narrative: Information has been received from a licensed practical nurse concerning a 30 year old male with asthma and no known allergies who on Jan 07 2005, at approximately 10:00am, was vaccinated IM in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 647724/0946N). Concomitant vaccination that day at the same time included a first dose in the left deltoid of influenza virus whole virion 3v vaccine inactivated (Fluzone) (Lot U1531AA). Other concomitant medication included fluticasone propionate (+) salmeterol xinafoate (Advair). zafirlukas (Accolate), ibuprofen, acetaminophen (Tylenol) and azithromycin (Zithromax. Illness at the time of vaccination included a URI and sinusitis, On Jan 09 2005, the patient developed redness, tenderness, swelling and pain in the vaccinated arm, with decreased range of motion, nausea and vomiting. On Jan 10 2004, the patient went to the emergency room, and subsequently, was hospitalized for cellulitis. The patient was treated with ampicillin sodium (+) sulbactam sodium (Unasyn), IV, methylprednisolone sodium succinate (Solu-medrol), IV, and acetaminophen (+) propoxyphene napsylate (Darvocet-N 100) while in the hospital. It was reported that the patient was discharged from the hospital. and subsequently, recovered. Follow up information has been received from a LPN and medical records. The nurse reported redness, swelling and pain at the site of injection along with a severe headache,. the patient went to the ER on Jan 09 2005 and got scripts for po amoxicillin (+) clavulanate potassium (Augmentin) and IM ceftriaxone sodium (Rocephin). Diagnosis was left arm cellulitis, The medical records indicated that on exam, the arm was very red (erythema) and hot (warmth) with swelling and fever. At the visit the patient reported that it hurt to raise or move the arm . Laboratory results from Jan 09 2005 included a WBC of 12.8 with segs of 88% and a sed rate of 35mm/hr. The nurse reported that the redness, pain, swelling and warmth at the site increased. The patient also had decreased ROM and nausea and vomiting developed. The patient was admitted to the hospital on Jan 10 2005 with diagnosis of cellulitis and sinusitis. medical records indicated that the chief complaint at admission included weakness, nausea, vomiting, headache and pain and redness in the left arm. Treatment included IV fluids, IV methylprednisolone sodium succinate (SOLU-MEDROL), IV ampicillin sodium  (+) sulbactam sodium (Unasyn), Iv metoclopramide hydrochloride (Reglan), guaifenesin (+) phenylephrine hydrochloride (+) phenypropanolamine hydrochloride (Entex PSE), acetaminophen (+) propoxyphene napsylate (Darvocet-N), saline spray and amantadine hydrochloride. Influenza AB screen neutrophil count and sed rate were all increased. See laboratory section for all relevant results. It was reported that the patient recovered on Jan 24 2005. Additional information is not expected.
Age: 31.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Feeling hot, Headache, Hypokinesia, Injection site oedema
Clinical narrative: Information has been received from a licensed practical nurse concerning a 30 year old male with asthma and no known allergies who on Jan 07 2005, at approximately 10:00am, was vaccinated IM in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 647724/0946N). Concomitant vaccination that day at the same time included a first dose in the left deltoid of influenza virus whole virion 3v vaccine inactivated (Fluzone) (Lot U1531AA). Other concomitant medication included fluticasone propionate (+) salmeterol xinafoate (Advair). zafirlukas (Accolate), ibuprofen, acetaminophen (Tylenol) and azithromycin (Zithromax. Illness at the time of vaccination included a URI and sinusitis, On Jan 09 2005, the patient developed redness, tenderness, swelling and pain in the vaccinated arm, with decreased range of motion, nausea and vomiting. On Jan 10 2004, the patient went to the emergency room, and subsequently, was hospitalized for cellulitis. The patient was treated with ampicillin sodium (+) sulbactam sodium (Unasyn), IV, methylprednisolone sodium succinate (Solu-medrol), IV, and acetaminophen (+) propoxyphene napsylate (Darvocet-N 100) while in the hospital. It was reported that the patient was discharged from the hospital. and subsequently, recovered. Follow up information has been received from a LPN and medical records. The nurse reported redness, swelling and pain at the site of injection along with a severe headache,. the patient went to the ER on Jan 09 2005 and got scripts for po amoxicillin (+) clavulanate potassium (Augmentin) and IM ceftriaxone sodium (Rocephin). Diagnosis was left arm cellulitis, The medical records indicated that on exam, the arm was very red (erythema) and hot (warmth) with swelling and fever. At the visit the patient reported that it hurt to raise or move the arm . Laboratory results from Jan 09 2005 included a WBC of 12.8 with segs of 88% and a sed rate of 35mm/hr. The nurse reported that the redness, pain, swelling and warmth at the site increased. The patient also had decreased ROM and nausea and vomiting developed. The patient was admitted to the hospital on Jan 10 2005 with diagnosis of cellulitis and sinusitis. medical records indicated that the chief complaint at admission included weakness, nausea, vomiting, headache and pain and redness in the left arm. Treatment included IV fluids, IV methylprednisolone sodium succinate (SOLU-MEDROL), IV ampicillin sodium  (+) sulbactam sodium (Unasyn), Iv metoclopramide hydrochloride (Reglan), guaifenesin (+) phenylephrine hydrochloride (+) phenypropanolamine hydrochloride (Entex PSE), acetaminophen (+) propoxyphene napsylate (Darvocet-N), saline spray and amantadine hydrochloride. Influenza AB screen neutrophil count and sed rate were all increased. See laboratory section for all relevant results. It was reported that the patient recovered on Jan 24 2005. Additional information is not expected.
Age: 31.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site pain, Injection site reaction, Laboratory test abnormal, Nausea, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 30 year old male with asthma and no known allergies who on Jan 07 2005, at approximately 10:00am, was vaccinated IM in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 647724/0946N). Concomitant vaccination that day at the same time included a first dose in the left deltoid of influenza virus whole virion 3v vaccine inactivated (Fluzone) (Lot U1531AA). Other concomitant medication included fluticasone propionate (+) salmeterol xinafoate (Advair). zafirlukas (Accolate), ibuprofen, acetaminophen (Tylenol) and azithromycin (Zithromax. Illness at the time of vaccination included a URI and sinusitis, On Jan 09 2005, the patient developed redness, tenderness, swelling and pain in the vaccinated arm, with decreased range of motion, nausea and vomiting. On Jan 10 2004, the patient went to the emergency room, and subsequently, was hospitalized for cellulitis. The patient was treated with ampicillin sodium (+) sulbactam sodium (Unasyn), IV, methylprednisolone sodium succinate (Solu-medrol), IV, and acetaminophen (+) propoxyphene napsylate (Darvocet-N 100) while in the hospital. It was reported that the patient was discharged from the hospital. and subsequently, recovered. Follow up information has been received from a LPN and medical records. The nurse reported redness, swelling and pain at the site of injection along with a severe headache,. the patient went to the ER on Jan 09 2005 and got scripts for po amoxicillin (+) clavulanate potassium (Augmentin) and IM ceftriaxone sodium (Rocephin). Diagnosis was left arm cellulitis, The medical records indicated that on exam, the arm was very red (erythema) and hot (warmth) with swelling and fever. At the visit the patient reported that it hurt to raise or move the arm . Laboratory results from Jan 09 2005 included a WBC of 12.8 with segs of 88% and a sed rate of 35mm/hr. The nurse reported that the redness, pain, swelling and warmth at the site increased. The patient also had decreased ROM and nausea and vomiting developed. The patient was admitted to the hospital on Jan 10 2005 with diagnosis of cellulitis and sinusitis. medical records indicated that the chief complaint at admission included weakness, nausea, vomiting, headache and pain and redness in the left arm. Treatment included IV fluids, IV methylprednisolone sodium succinate (SOLU-MEDROL), IV ampicillin sodium  (+) sulbactam sodium (Unasyn), Iv metoclopramide hydrochloride (Reglan), guaifenesin (+) phenylephrine hydrochloride (+) phenypropanolamine hydrochloride (Entex PSE), acetaminophen (+) propoxyphene napsylate (Darvocet-N), saline spray and amantadine hydrochloride. Influenza AB screen neutrophil count and sed rate were all increased. See laboratory section for all relevant results. It was reported that the patient recovered on Jan 24 2005. Additional information is not expected.
Age: 31.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Red blood cell abnormality, Tenderness, Urine analysis abnormal, Vomiting, White blood cell count increased
Clinical narrative: Information has been received from a licensed practical nurse concerning a 30 year old male with asthma and no known allergies who on Jan 07 2005, at approximately 10:00am, was vaccinated IM in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 647724/0946N). Concomitant vaccination that day at the same time included a first dose in the left deltoid of influenza virus whole virion 3v vaccine inactivated (Fluzone) (Lot U1531AA). Other concomitant medication included fluticasone propionate (+) salmeterol xinafoate (Advair). zafirlukas (Accolate), ibuprofen, acetaminophen (Tylenol) and azithromycin (Zithromax. Illness at the time of vaccination included a URI and sinusitis, On Jan 09 2005, the patient developed redness, tenderness, swelling and pain in the vaccinated arm, with decreased range of motion, nausea and vomiting. On Jan 10 2004, the patient went to the emergency room, and subsequently, was hospitalized for cellulitis. The patient was treated with ampicillin sodium (+) sulbactam sodium (Unasyn), IV, methylprednisolone sodium succinate (Solu-medrol), IV, and acetaminophen (+) propoxyphene napsylate (Darvocet-N 100) while in the hospital. It was reported that the patient was discharged from the hospital. and subsequently, recovered. Follow up information has been received from a LPN and medical records. The nurse reported redness, swelling and pain at the site of injection along with a severe headache,. the patient went to the ER on Jan 09 2005 and got scripts for po amoxicillin (+) clavulanate potassium (Augmentin) and IM ceftriaxone sodium (Rocephin). Diagnosis was left arm cellulitis, The medical records indicated that on exam, the arm was very red (erythema) and hot (warmth) with swelling and fever. At the visit the patient reported that it hurt to raise or move the arm . Laboratory results from Jan 09 2005 included a WBC of 12.8 with segs of 88% and a sed rate of 35mm/hr. The nurse reported that the redness, pain, swelling and warmth at the site increased. The patient also had decreased ROM and nausea and vomiting developed. The patient was admitted to the hospital on Jan 10 2005 with diagnosis of cellulitis and sinusitis. medical records indicated that the chief complaint at admission included weakness, nausea, vomiting, headache and pain and redness in the left arm. Treatment included IV fluids, IV methylprednisolone sodium succinate (SOLU-MEDROL), IV ampicillin sodium  (+) sulbactam sodium (Unasyn), Iv metoclopramide hydrochloride (Reglan), guaifenesin (+) phenylephrine hydrochloride (+) phenypropanolamine hydrochloride (Entex PSE), acetaminophen (+) propoxyphene napsylate (Darvocet-N), saline spray and amantadine hydrochloride. Influenza AB screen neutrophil count and sed rate were all increased. See laboratory section for all relevant results. It was reported that the patient recovered on Jan 24 2005. Additional information is not expected.
Age: 31.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: White blood cell disorder
Clinical narrative: Information has been received from a licensed practical nurse concerning a 30 year old male with asthma and no known allergies who on Jan 07 2005, at approximately 10:00am, was vaccinated IM in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 647724/0946N). Concomitant vaccination that day at the same time included a first dose in the left deltoid of influenza virus whole virion 3v vaccine inactivated (Fluzone) (Lot U1531AA). Other concomitant medication included fluticasone propionate (+) salmeterol xinafoate (Advair). zafirlukas (Accolate), ibuprofen, acetaminophen (Tylenol) and azithromycin (Zithromax. Illness at the time of vaccination included a URI and sinusitis, On Jan 09 2005, the patient developed redness, tenderness, swelling and pain in the vaccinated arm, with decreased range of motion, nausea and vomiting. On Jan 10 2004, the patient went to the emergency room, and subsequently, was hospitalized for cellulitis. The patient was treated with ampicillin sodium (+) sulbactam sodium (Unasyn), IV, methylprednisolone sodium succinate (Solu-medrol), IV, and acetaminophen (+) propoxyphene napsylate (Darvocet-N 100) while in the hospital. It was reported that the patient was discharged from the hospital. and subsequently, recovered. Follow up information has been received from a LPN and medical records. The nurse reported redness, swelling and pain at the site of injection along with a severe headache,. the patient went to the ER on Jan 09 2005 and got scripts for po amoxicillin (+) clavulanate potassium (Augmentin) and IM ceftriaxone sodium (Rocephin). Diagnosis was left arm cellulitis, The medical records indicated that on exam, the arm was very red (erythema) and hot (warmth) with swelling and fever. At the visit the patient reported that it hurt to raise or move the arm . Laboratory results from Jan 09 2005 included a WBC of 12.8 with segs of 88% and a sed rate of 35mm/hr. The nurse reported that the redness, pain, swelling and warmth at the site increased. The patient also had decreased ROM and nausea and vomiting developed. The patient was admitted to the hospital on Jan 10 2005 with diagnosis of cellulitis and sinusitis. medical records indicated that the chief complaint at admission included weakness, nausea, vomiting, headache and pain and redness in the left arm. Treatment included IV fluids, IV methylprednisolone sodium succinate (SOLU-MEDROL), IV ampicillin sodium  (+) sulbactam sodium (Unasyn), Iv metoclopramide hydrochloride (Reglan), guaifenesin (+) phenylephrine hydrochloride (+) phenypropanolamine hydrochloride (Entex PSE), acetaminophen (+) propoxyphene napsylate (Darvocet-N), saline spray and amantadine hydrochloride. Influenza AB screen neutrophil count and sed rate were all increased. See laboratory section for all relevant results. It was reported that the patient recovered on Jan 24 2005. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: PPV, TTOX, PPV, TTOX
Symptoms: Cellulitis, Erythema, Headache, Hypokinesia, Injection site reaction
Clinical narrative: Information has been received from a physician concerning a 67 year old female who on 01-APR-2005 was vaccinated for the first time with Pneumovax 23 (lot #650327/0792P) in her left arm. Concomitant therapy included tetanus toxoid administered 01-APR-2005 in right arm. Several days later, her son reported to physician that she developed a local injection site reaction on her left arm and developed a fever (measurement not reported). On approximately 04-APR-2005, the third day after vaccination, the pt visited an emergency room and was given antibiotics. On 08-APR-2005, the pt had fever of 40 degrees C and was admitted to the hospital and given IV antibiotics. At the time of the report, the pt was improving. Left arm local injection site reaction and fever were considered to be disabling and an other important medical event (OMIC). Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV, TTOX, PPV, TTOX
Symptoms: Leukocytosis, Malaise, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 67 year old female who on 01-APR-2005 was vaccinated for the first time with Pneumovax 23 (lot #650327/0792P) in her left arm. Concomitant therapy included tetanus toxoid administered 01-APR-2005 in right arm. Several days later, her son reported to physician that she developed a local injection site reaction on her left arm and developed a fever (measurement not reported). On approximately 04-APR-2005, the third day after vaccination, the pt visited an emergency room and was given antibiotics. On 08-APR-2005, the pt had fever of 40 degrees C and was admitted to the hospital and given IV antibiotics. At the time of the report, the pt was improving. Left arm local injection site reaction and fever were considered to be disabling and an other important medical event (OMIC). Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV, TTOX, PPV, TTOX
Symptoms: Injection site reaction, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 67 year old female who on 01-APR-2005 was vaccinated for the first time with Pneumovax 23 (lot #650327/0792P) in her left arm. Concomitant therapy included tetanus toxoid administered 01-APR-2005 in right arm. Several days later, her son reported to physician that she developed a local injection site reaction on her left arm and developed a fever (measurement not reported). On approximately 04-APR-2005, the third day after vaccination, the pt visited an emergency room and was given antibiotics. On 08-APR-2005, the pt had fever of 40 degrees C and was admitted to the hospital and given IV antibiotics. At the time of the report, the pt was improving. Left arm local injection site reaction and fever were considered to be disabling and an other important medical event (OMIC). Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Agitation, Arthralgia, Crying, Headache, Injection site pain
Clinical narrative: Information has been received from a consumer concerning a 9 year old female with asthma and allergic rhinitis who on April 05 2005 was vaccinated IM with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included fluticasone propionate (+) salmeterol xinafoate (Advair), loratadine (Claritin), budesonide (Rhinocort) and montelukast sodium. On Apr 05 2005, the patient experienced severe pain in the right arm, 102.5 degrees F fever, flu symptoms, headache, redness shoulder to elbow on right arm, and rash the size of a half dollar. Unspecified medical attention was sought. As of Apr 08 2005 the patient was recovering, although it was reported that she still has large rash on right arm. No product quality complaint was involved. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site rash, Myalgia, Pyrexia, Sleep disorder, Urticaria
Clinical narrative: Information has been received from a consumer concerning a 9 year old female with asthma and allergic rhinitis who on April 05 2005 was vaccinated IM with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included fluticasone propionate (+) salmeterol xinafoate (Advair), loratadine (Claritin), budesonide (Rhinocort) and montelukast sodium. On Apr 05 2005, the patient experienced severe pain in the right arm, 102.5 degrees F fever, flu symptoms, headache, redness shoulder to elbow on right arm, and rash the size of a half dollar. Unspecified medical attention was sought. As of Apr 08 2005 the patient was recovering, although it was reported that she still has large rash on right arm. No product quality complaint was involved. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Headache, Hypersensitivity, Influenza like illness, Pain, Pyrexia
Clinical narrative: Information has been received from a consumer concerning a 9 year old female with asthma and allergic rhinitis who on April 05 2005 was vaccinated IM with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included fluticasone propionate (+) salmeterol xinafoate (Advair), loratadine (Claritin), budesonide (Rhinocort) and montelukast sodium. On Apr 05 2005, the patient experienced severe pain in the right arm, 102.5 degrees F fever, flu symptoms, headache, redness shoulder to elbow on right arm, and rash the size of a half dollar. Unspecified medical attention was sought. As of Apr 08 2005 the patient was recovering, although it was reported that she still has large rash on right arm. No product quality complaint was involved. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Rash
Clinical narrative: Information has been received from a consumer concerning a 9 year old female with asthma and allergic rhinitis who on April 05 2005 was vaccinated IM with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included fluticasone propionate (+) salmeterol xinafoate (Advair), loratadine (Claritin), budesonide (Rhinocort) and montelukast sodium. On Apr 05 2005, the patient experienced severe pain in the right arm, 102.5 degrees F fever, flu symptoms, headache, redness shoulder to elbow on right arm, and rash the size of a half dollar. Unspecified medical attention was sought. As of Apr 08 2005 the patient was recovering, although it was reported that she still has large rash on right arm. No product quality complaint was involved. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HIBV, PPV, HIBV, PPV
Symptoms: Cellulitis, Injection site reaction, Leukocytosis
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old male with multiple allergies and a history of chronic sinus infections, who on Apr 04 2005 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot 649912/0529P). Concomitant therapy given in the opposite arm included a dose of Hib conj vaccine (CM197) (Hib titer), desloratadine (Clarinex), triamcinolone acetonide (Nasacort AQ). On Apr 05 2005, it was reported that the patients arms were hurting, had a headache, was tired, has swollen glands and a temperature of 99F. On Apr 07 2005, a phone call was received from his mother and she reported that on the previous day, his injection site was infected, he had temperature of 102F, and stomach cramps. He was treated with cephalexin (Keflex) from the primary care physician. That same day, they returned to the primary card physician and the patient received a shot in the butt to fight the infection at the injection site. It was also reported that the patient felt sick with vomiting for 14 hours. On Apr 08 2005, a message was received that said the patient was treated in the ER but he was not admitted to the hospital. The patients outcome was unknown. No product quality complaint was involved. Additional information has been requested. It was also reported that an additional patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649912/0529P) and experienced adverse events (WAES0504USA01407).
Age: 12.0
Sex: M
Vaccine: HIBV, PPV, HIBV, PPV
Symptoms: Abdominal pain, Fatigue, Headache, Injection site infection, Lymphadenopathy
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old male with multiple allergies and a history of chronic sinus infections, who on Apr 04 2005 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot 649912/0529P). Concomitant therapy given in the opposite arm included a dose of Hib conj vaccine (CM197) (Hib titer), desloratadine (Clarinex), triamcinolone acetonide (Nasacort AQ). On Apr 05 2005, it was reported that the patients arms were hurting, had a headache, was tired, has swollen glands and a temperature of 99F. On Apr 07 2005, a phone call was received from his mother and she reported that on the previous day, his injection site was infected, he had temperature of 102F, and stomach cramps. He was treated with cephalexin (Keflex) from the primary care physician. That same day, they returned to the primary card physician and the patient received a shot in the butt to fight the infection at the injection site. It was also reported that the patient felt sick with vomiting for 14 hours. On Apr 08 2005, a message was received that said the patient was treated in the ER but he was not admitted to the hospital. The patients outcome was unknown. No product quality complaint was involved. Additional information has been requested. It was also reported that an additional patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649912/0529P) and experienced adverse events (WAES0504USA01407).
Age: 12.0
Sex: M
Vaccine: HIBV, PPV, HIBV, PPV
Symptoms: Malaise, Pain, Pyrexia, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old male with multiple allergies and a history of chronic sinus infections, who on Apr 04 2005 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot 649912/0529P). Concomitant therapy given in the opposite arm included a dose of Hib conj vaccine (CM197) (Hib titer), desloratadine (Clarinex), triamcinolone acetonide (Nasacort AQ). On Apr 05 2005, it was reported that the patients arms were hurting, had a headache, was tired, has swollen glands and a temperature of 99F. On Apr 07 2005, a phone call was received from his mother and she reported that on the previous day, his injection site was infected, he had temperature of 102F, and stomach cramps. He was treated with cephalexin (Keflex) from the primary care physician. That same day, they returned to the primary card physician and the patient received a shot in the butt to fight the infection at the injection site. It was also reported that the patient felt sick with vomiting for 14 hours. On Apr 08 2005, a message was received that said the patient was treated in the ER but he was not admitted to the hospital. The patients outcome was unknown. No product quality complaint was involved. Additional information has been requested. It was also reported that an additional patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649912/0529P) and experienced adverse events (WAES0504USA01407).
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Malaise
Clinical narrative: Initial and follow up information has been received from a licensed visiting nurse concerning a 70 year old white female with an allergy to aspirin and Celecoxib (Celebrex), colon polyps, cecal arteriovenous malformation, borderline hypertension, and abnormal chest x ray who on Apr 28 2005, during an annual check up, was vaccinated intramuscularly in the right deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649694/0386P). It was reported that the patient had received a prior dose of vaccine in November 1997. On Apr 29 2005, the patient developed redness, warmth, swelling, and aching at the site. Some of the swelling and pain went from the site to the elbow. In follow up, the nurse reported that the patient also reported feeling weird, which was most likely unrelated to the injection, as the patient had not eaten. The patient sought unspecified medical attention and was instructed to use cold compresses and acetaminophen (Tylenol). In follow up, the nurse reported that an emergency room doctor visit was not required. Subsequently, the patient recovered within 1 to 2 days. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Feeling hot, Injection site hypersensitivity, Injection site oedema, Injection site pain, Malaise
Clinical narrative: Initial and follow up information has been received from a licensed visiting nurse concerning a 70 year old white female with an allergy to aspirin and Celecoxib (Celebrex), colon polyps, cecal arteriovenous malformation, borderline hypertension, and abnormal chest x ray who on Apr 28 2005, during an annual check up, was vaccinated intramuscularly in the right deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649694/0386P). It was reported that the patient had received a prior dose of vaccine in November 1997. On Apr 29 2005, the patient developed redness, warmth, swelling, and aching at the site. Some of the swelling and pain went from the site to the elbow. In follow up, the nurse reported that the patient also reported feeling weird, which was most likely unrelated to the injection, as the patient had not eaten. The patient sought unspecified medical attention and was instructed to use cold compresses and acetaminophen (Tylenol). In follow up, the nurse reported that an emergency room doctor visit was not required. Subsequently, the patient recovered within 1 to 2 days. Additional information is not expected.
Age: 77.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 77 year old white female with allergies to penicillin, morphine, codeine, tramadol HCL, propoxyphene napsylate/acetaminophen, meperidine HCL, and coradone, and hypertension, fibrocystic breast disease, degenerative disc disease, osteoarthritis, mild mitral regurgitation, hypothyroid, tinnitus, malt lymphoma, and a history of ablation, peptic ulcer disease, atrial fibrillation, and pulmonary embolism who on Feb 14 2005 was vaccinated intramuscularly in the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649694/0386P). It was reported that the patient received a first dose of pneumococcal 23v polysaccharide vaccine in 2000. On Feb 17 2005, the patient developed redness, warmth, swelling, and aching at the site. Some of the swelling and pain went from the site to the elbow. the patient sought unspecified medical attention and was instructed to use cold compresses and acetaminophen (Tylenol). Subsequently, the patient recovered within 1 to 2 days. No additional information is expected.
Age: 77.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Feeling hot, Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 77 year old white female with allergies to penicillin, morphine, codeine, tramadol HCL, propoxyphene napsylate/acetaminophen, meperidine HCL, and coradone, and hypertension, fibrocystic breast disease, degenerative disc disease, osteoarthritis, mild mitral regurgitation, hypothyroid, tinnitus, malt lymphoma, and a history of ablation, peptic ulcer disease, atrial fibrillation, and pulmonary embolism who on Feb 14 2005 was vaccinated intramuscularly in the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649694/0386P). It was reported that the patient received a first dose of pneumococcal 23v polysaccharide vaccine in 2000. On Feb 17 2005, the patient developed redness, warmth, swelling, and aching at the site. Some of the swelling and pain went from the site to the elbow. the patient sought unspecified medical attention and was instructed to use cold compresses and acetaminophen (Tylenol). Subsequently, the patient recovered within 1 to 2 days. No additional information is expected.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Feeling hot, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 74 year old white female with coronary artery disease, hypertension, hyperlipoproteinemia, macular degeneration in right eye, and chokes on large pills who on Apr 26 2005 was vaccinated intramuscularly in the right deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649694/0386P). It was reported that the patient received a first dose in 1999. On Apr 27 2005, the patient developed redness, warmth, swelling, and aching at the site. Some of the swelling and paint went from the site to the elbow. The paitent sought unpsecified medical attention and was instructed to use cold compresses and acetaminophen (Tylenol). Subsequently, the patient recovered within 1 to 2 days. No additional information is expected.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Feeling hot, Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 74 year old white female with coronary artery disease, hypertension, hyperlipoproteinemia, macular degeneration in right eye, and chokes on large pills who on Apr 26 2005 was vaccinated intramuscularly in the right deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649694/0386P). It was reported that the patient received a first dose in 1999. On Apr 27 2005, the patient developed redness, warmth, swelling, and aching at the site. Some of the swelling and paint went from the site to the elbow. The paitent sought unpsecified medical attention and was instructed to use cold compresses and acetaminophen (Tylenol). Subsequently, the patient recovered within 1 to 2 days. No additional information is expected.
Age: 77.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Feeling hot, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 76 year old white female with hypertension, hyperliproproteinuria, migraines, sinusitis, osteoarthritis, low back pain, low white blood cell count, allergies to metoclopramide and guaifenesin/dextromethorphan and a history of bell's palsy who on Apr 25 2005 was vaccinated intramuscularly in the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649694/0386P). It was reported that the patient received a first vaccine in 1997. On Apr 28 2005, the patient developed redness, warmth, swelling, and aching at the site. Some of the swelling and pain went from the site to the elbow. The patient sought unspecified medical attention and was instructed to use cold compresses and acetaminophen (Tylenol). Subsequently, the patient recovered with 1 to 2 days. No additional information is expected.
Age: 77.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Feeling hot, Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 76 year old white female with hypertension, hyperliproproteinuria, migraines, sinusitis, osteoarthritis, low back pain, low white blood cell count, allergies to metoclopramide and guaifenesin/dextromethorphan and a history of bell's palsy who on Apr 25 2005 was vaccinated intramuscularly in the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649694/0386P). It was reported that the patient received a first vaccine in 1997. On Apr 28 2005, the patient developed redness, warmth, swelling, and aching at the site. Some of the swelling and pain went from the site to the elbow. The patient sought unspecified medical attention and was instructed to use cold compresses and acetaminophen (Tylenol). Subsequently, the patient recovered with 1 to 2 days. No additional information is expected.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Chills, Hypersensitivity, Infection, Injection site erythema
Clinical narrative: Initial and follow up information has been received from a licensed practical nurse concerning a 77 yr old retired female who on 15Oct04 at 9:50AM was vaccinated IM in the right deltoid, with a first dose of pneumococcal 23v polysaccharide vaccine (lot 649696/0490P). Concomitant therapy included a fourth dose of influenza virus split virion 3v vaccine inactivated (Fluzone) (lot V1380AA) administered IM in the left deltoid. It was reported that the pt developed red, swollen arm at the injection site after receiving pneumococcal 23v polysaccharide vaccine. It was also reported that the pt was seen in clinic and diagnosed with cellulitis. The pt was treated with antibiotic as an intervention. The reporter indicated that cellulitis was considered to be an other important medical event (OMIC). The nurse reported that 2 other female pt's had similar experiences with pneumococcal 23v polysaccharide vaccine (WAES0410USA02650 and 0410USA03090) in the past two weeks. There was no product quality complaint involved. Follow up information from the nurse indicated that the pt developed pain, erythema and swelling in right upper arm about 2-3 hours after injection. The pt also had chills and nausea but no fever. The nurse suspected an infection or possible allergic reaction however the pt has no  history of drug allergies. It was also reported that the pt recovered (date unspecified).
Age: 78.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site oedema, Injection site pain, Injection site reaction, Nausea
Clinical narrative: Initial and follow up information has been received from a licensed practical nurse concerning a 77 yr old retired female who on 15Oct04 at 9:50AM was vaccinated IM in the right deltoid, with a first dose of pneumococcal 23v polysaccharide vaccine (lot 649696/0490P). Concomitant therapy included a fourth dose of influenza virus split virion 3v vaccine inactivated (Fluzone) (lot V1380AA) administered IM in the left deltoid. It was reported that the pt developed red, swollen arm at the injection site after receiving pneumococcal 23v polysaccharide vaccine. It was also reported that the pt was seen in clinic and diagnosed with cellulitis. The pt was treated with antibiotic as an intervention. The reporter indicated that cellulitis was considered to be an other important medical event (OMIC). The nurse reported that 2 other female pt's had similar experiences with pneumococcal 23v polysaccharide vaccine (WAES0410USA02650 and 0410USA03090) in the past two weeks. There was no product quality complaint involved. Follow up information from the nurse indicated that the pt developed pain, erythema and swelling in right upper arm about 2-3 hours after injection. The pt also had chills and nausea but no fever. The nurse suspected an infection or possible allergic reaction however the pt has no  history of drug allergies. It was also reported that the pt recovered (date unspecified).