chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Skin warm
Clinical narrative: Information has been received from a 67 year old female consumer with myelodysplastic syndrome and no known drug reactions/allergies, who on 12-APR-2011 was vaccinated with a dose of PNEUMOVAX 23 (lot number not provided). Concomitant therapy included PROCRIT, GLUCOPHAGE, SYNTHROID, PROTONIX and clonazepam. The consumer reported that on 12-APR-2011, within 5 or 10 minutes of receiving the dose of PNEUMOVAX 23, she had severe reaction. She had severe flushing of her face, and also her face was red and hot. The consumer also said that she experience weakness and inability to walk or stand. She could not hold a cup of water that she was given. The patient stated that she got the shot in her hip and said that she had severe pain in her back, on the same side as the injection was given. The patient also experienced a severe headache. The patient also reported that she developed black circles under her eyes. The patient sought unspecified medical attention. The patient was given cortisone shot to help her with the reaction. No labs diagnostic tests were performed. It was reported that after an hour or two the patient was able to drive herself home. At the time of the report, the patient still had some redness in her face and she thought she might had a dull headache, but none of the other symptoms. Follow up information indicated that on 13-APR-2011 (previously reported as 12-APR-2011) the patient was vaccinated with a dose of PNEUMOVAX 23 (lot umber not provided) and after she received the vaccine her eyes sunked in, turned black and she had a pain in her right arm. It was reported that the patient did not seek medical attention. No treatment was given for the adverse events. No lab diagnostic test were performed. The patient was reported as not recovered. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Headache, Pain, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 56 year old male patient who on 12-APR-2011, was vaccinated with a dose of 0.5 mL PNEUMOVAX 23 intramuscularly, in the right arm (lot number 667445/0993z, Exp. 05-JAN-2012). On 14-APR-2011, the patient was seen in the doctor's office with a severe headache. At the time of the report of the outcome of the patient was unknown. Follow up information has been received from a registered nurse concerning the patient with no illness at time of vaccination, who on 12-APR-2011 at 10:00 was vaccinated with a first dose of PNEUMOVAX 23. On 13-APR-2011 (previously reported as 14-APR-2011), the patient experienced 3 days of erythema upper arm, aching, fever < 100 degrees and moderate to severe headache. There were no Lab diagnostic/studies performed. The patient recovered on 16-APR-2011. No further information is available.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site induration, Injection site rash, Skin tightness, Skin warm
Clinical narrative: Information has been received from a healthcare worker concerning a 53 year old female patient with no pertinent medical history and no drug reactions or allergies who on 15-APR-2011 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 668008/1157Z, expire date 08-MAR-2012), 0.5 ml, intramuscularly. There was no concomitant medication. The healthcare worker stated that on 16-APR-2011, the patient reported that her skin was tight from her shoulder to the area just above her elbow. The area was hot to the touch, very red and there was a hard bump at the injection. On an unspecified date, the patient went to the office and was evaluated by the physician. The physician noted that the "bump" was the size of a quarter and hard to the touch. The physician recommended cold compress, TYLENOL as needed and the physician prescribed ZYRTEC for the patient. There were no laboratory diagnostics tests performed. At the time of the report, the patient had not recovered. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Erythema, Induration, Mass, Skin warm
Clinical narrative: Information has been received from a healthcare worker concerning a male patient who by the "end of February 2011" approximately 28-FEB-2011, was vaccinated with a dose of PNEUMOVAX 23 0.5 ml, intramuscularly in the arm (Lot number 667914/1067z, expiration date 29-FEB-2012). The health care worker reported that by the "end of February 2011" one day after the patient got the vaccine, the patient's arm became red and warm after receiving vaccine and he developed a bump that was hard to the touch, the bump was the size of a quarter. Patient sought unspecified medical attention. Laboratory diagnostics were not performed. The patient recovered "within 3 to 5 days after reporting event". This is one of five reports received from the same source. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: Information has been received from a healthcare worker concerning a 53 year old female patient with hypertension and no known allergies, who on 05-APR-2011 was vaccinated with a dose of PNEUMOVAX 23 0.5 ml, intramuscularly in the left upper arm (Lot number 667914/1067Z, expiration date: 28-FEB-2012). The health care worker reported that on 06-APR-2011 the patient went to the office because area around injection site was red, warm to touch and there was a hard bump the size of a quarter at the injection site. The physician recommended cold compress. Laboratory diagnostics studies were not performed. At the time of the report, the patient recovered 4 days later, on 10-APR-2011. This is one of five reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Mass, Skin warm
Clinical narrative: Information has been received from a healthcare worker concerning a female patient who by the "end of February 2011" an approximately 28-FEB-2011, was vaccinated with a dose of PNEUMOVAX 23 0.5 ml, intramuscularly (Lot number 667914/1067Z, expiration date 08-FEB-2012). The health care worker reported that by the "end of February 2011" on approximately 28-FEB-2011, the patient's arm became red and warm after receiving vaccine and she developed a bump that was hard to the touch, the bump was the size of a quarter. Patient sought unspecified medical attention. The patient recovered "3 to 5 days after reporting the adverse event". This is one of five reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: FLU3, PPV, TTOX
Symptoms: Adverse reaction, Drug administration error
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot# unknown) and a dose of AFLURIA (Lot# unknown) in the same arm at the same time. Concomitantly at that time, the patient received a dose of tetanus toxoid (manufacturer unknown) in the other arm. It was reported that the patient had a reaction in the arm where the patient received PNEUMOVAX 23 and AFLURIA. It was stated that PNEUMOVAX 23 was not supposed to be administered in the same arm with AFLURIA. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. Additional information is not expected.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Fatigue, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Information has been received from a 67 year old male physician with atrial fibrillation an no know drug reactions/allergies, who on 29-APR-2011 was vaccinated into the deltoid with a dose of PNEUMOVAX 23 (lot number not provided). Concomitant therapy included TOPROL XL (tablets) and unspecified blood pressure medication. Physician reported that on 30-APR-2011, he experienced soreness at the injection site, fever, shaking chills, muscle aches and fatigue. It was unspecified if the patient sought medical attention. No lab diagnostic studies were performed. Physician reported that he treated himself with hydration and unspecified doses of NAPROSYN. Physician reported that he was more active on Sunday, 30-APR-2011, but that he had to rest following each activity. Physician reported that on 02-MAY-2011 he was not recovered yet, but he felt well enough to return to work. The physician also mentioned that he always experienced similar reactions to the annual influenza vaccine (manufacturer unspecified). Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Tremor
Clinical narrative: Information has been received from a 67 year old male physician with atrial fibrillation an no know drug reactions/allergies, who on 29-APR-2011 was vaccinated into the deltoid with a dose of PNEUMOVAX 23 (lot number not provided). Concomitant therapy included TOPROL XL (tablets) and unspecified blood pressure medication. Physician reported that on 30-APR-2011, he experienced soreness at the injection site, fever, shaking chills, muscle aches and fatigue. It was unspecified if the patient sought medical attention. No lab diagnostic studies were performed. Physician reported that he treated himself with hydration and unspecified doses of NAPROSYN. Physician reported that he was more active on Sunday, 30-APR-2011, but that he had to rest following each activity. Physician reported that on 02-MAY-2011 he was not recovered yet, but he felt well enough to return to work. The physician also mentioned that he always experienced similar reactions to the annual influenza vaccine (manufacturer unspecified). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a medical assistant concerning a patient who on 19-APR-2011 was might or might not intramuscularly vaccinated with a dose of PNEUMOVAX 23 (dose and lot# not reported). The patient's arm was pierced with a needle but it was unsure if PNEUMOVAX 23 was drawn into the syring prior to attempting the intramuscular injection. No adverse symptoms reported. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 64 year old male with high cholesterol and no drug reactions or allergies who on 29-SEP-2010 was vaccinated SC with PNEUMOVAX 23 at the left deltoid. Concomitant therapy included simvastatin (manufacturer unspecified). The next day on 30-SEP-2010 (also reported on 29-SEP-2010) the patient's left deltoid (the site of administration) swelled to twice its normal size with erythema, edema and tenderness. The patient presented to the physician the following day, 2 days after the shot. The physician prescribed 50mg of BENADRYL 3 times a day and AUGMENTIN 500mg 3 times a day for 3 days. No lab/diagnostics studios were performed. Therapy was reported as continued. As of 04-OCT-2010, the symptoms had almost completely resolved. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Injection site warmth, Mobility decreased, Musculoskeletal stiffness, Pain
Clinical narrative: Information has been received from a Pharmacist (Pharm.D.) concerning a 48 year old female with no pertinent medical history and no drug reactions/allergies who on 30-SEP-2010, was vaccinated intramuscularly in right deltoid with a 0.5 mL dose of PNEUMOVAX 23 (lot#665904/0866z; exp: 04-Jul-2011). There was no concomitant medication. On the evening of 30-SEP-2010, the patient experienced having difficulty in raising up her arm, "flu-like symptoms", stiffness, pain, and area from the injection site to the elbow were warm. Pharmacist stated patient contacted him and he recommended patient increase fluids, and took diphenhydramine hydrochloride. Pharmacist stated he knew patient did increase her fluid intake but he was not sure if she took any diphenhydramine hydrochloride. At the time of the report, patient had recovered from these adverse events (date not specified). Pharmacist would like lot check. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question (lot # 665904/0866Z) were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center of Biologics Evaluation and Research and was released. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a pharmacist concerning a female patient who on unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot# not reported). The pharmacist stated that a patient had an intense reaction to the PNEUMOVAX 23 (date unspecified). At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Acne, Burning sensation, Chills, Erythema, Muscle tightness
Clinical narrative: Information has been received from a 71 year old male patient with "CT dyes" allergy hay fever and gastroparesis who in 1999 was vaccinated with a first dose of PNEUMOVAX 23 (Lot# not reported), in 2004 was vaccinated with a second dose of PNEUMOVAX 23 (Lot# not reported) (unknown if consumer had previous problems with prior vaccinations). On 19-OCT-2010, the patient was vaccinated with a third dose of PNEUMOVAX 23 (Lot# 665925/0932Z). Concomitant therapy included ACIPHEX, montelukast sodium (MSD), ezetimibe (MSD) and NORVASC. The patient stated that on 19-OCT-2010, he experienced chills and his "fingers burned". On 20-OCT-2010 his left arm became red and felt like it was "burning". The patient saw the physician on 21-OCT-2011 and was given "a shot of steroids, and was given a prescription for KEFLEX antibiotic for 5 days". The consumer stated that after five days on KEFLEX his arm "went from red to orange to yellow to somewhat normal". On approximately 30-OCT-2010 the patient developed pimple under the arm and put NEOSPORIN on the pimple and the pimple went away 3-4 days later. It was also reported that on approximately 24-NOV-2010 the patient developed a new growth in my left armpit. The new growth had started as a pimple and it got white with puss, he also went to the doctor for his neck pain and tightness in his left arm and shoulder which was emulating to his neck; his physician put him on BACTRIM for the growth in his armpit, the patient mentioned that this growth was healing, but still had a small area of redness and on 05-DEC-2010 he developed two new "growths" in his left armpit, one was about an inch long and the other was 1/2 inch long", the growths were described as red raised areas without any drainage, which were present at the time of the report. On unspecified date on X-RAY was performed (no results provided). The patient stated that "all my symptoms are related to the PNEUMOVAX 23." The patient reported he has not recovered. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Neck pain, X-ray
Clinical narrative: Information has been received from a 71 year old male patient with "CT dyes" allergy hay fever and gastroparesis who in 1999 was vaccinated with a first dose of PNEUMOVAX 23 (Lot# not reported), in 2004 was vaccinated with a second dose of PNEUMOVAX 23 (Lot# not reported) (unknown if consumer had previous problems with prior vaccinations). On 19-OCT-2010, the patient was vaccinated with a third dose of PNEUMOVAX 23 (Lot# 665925/0932Z). Concomitant therapy included ACIPHEX, montelukast sodium (MSD), ezetimibe (MSD) and NORVASC. The patient stated that on 19-OCT-2010, he experienced chills and his "fingers burned". On 20-OCT-2010 his left arm became red and felt like it was "burning". The patient saw the physician on 21-OCT-2011 and was given "a shot of steroids, and was given a prescription for KEFLEX antibiotic for 5 days". The consumer stated that after five days on KEFLEX his arm "went from red to orange to yellow to somewhat normal". On approximately 30-OCT-2010 the patient developed pimple under the arm and put NEOSPORIN on the pimple and the pimple went away 3-4 days later. It was also reported that on approximately 24-NOV-2010 the patient developed a new growth in my left armpit. The new growth had started as a pimple and it got white with puss, he also went to the doctor for his neck pain and tightness in his left arm and shoulder which was emulating to his neck; his physician put him on BACTRIM for the growth in his armpit, the patient mentioned that this growth was healing, but still had a small area of redness and on 05-DEC-2010 he developed two new "growths" in his left armpit, one was about an inch long and the other was 1/2 inch long", the growths were described as red raised areas without any drainage, which were present at the time of the report. On unspecified date on X-RAY was performed (no results provided). The patient stated that "all my symptoms are related to the PNEUMOVAX 23." The patient reported he has not recovered. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a licensed practitioner nurse concerning a patient who on an unspecified date was vaccinated IM with 0.5 ml of PNEUMOVAX 23 (lot# 667913/1021z). It was reported that the patient experienced extensive redness, pain and feeling of heat at injection site. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who on an unspecified date was vaccinated IM with 0.5 ml of PNEUMOVAX 23 (lot# 667913/1021z). It was reported that the patient experienced extensive redness, pain and feeling of heat at injection site. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning an adult patient who on approximately 18-OCT-2010 ("this week") was vaccinated with a dose of PNEUMOVAX 23 (Lot # 665925/0932Z). On approximately 18-OCT-2010 the patient developed adverse reactions. Injection site reactions included swelling, erythema, and pain. The nurse requested a lot check. At the time of the report the outcome of the patient was unknown. A lot check has been initiated. 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. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Adverse reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning an adult patient who on approximately 18-OCT-2010 ("this week") was vaccinated with a dose of PNEUMOVAX 23 (Lot # 665925/0932Z). On approximately 18-OCT-2010 the patient developed adverse reactions. Injection site reactions included swelling, erythema, and pain. The nurse requested a lot check. At the time of the report the outcome of the patient was unknown. A lot check has been initiated. 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 of Biologics Evaluation and Research and was released. This is one of several reports received from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Information has been received from a physician concerning a 60 year old female with mold allergies and diabetes who in November 2010, was vaccinated IM with a 0.5 ml dose of PNEUMOVAX 23 "for disease prevention" (lot # not provided). In November 2010, the patient had a localized reaction to the injection of PNEUMOVAX 23, it was red warm and swollen at the injection site. Patient sought unspecified medical attention. Treatment given for AE included BENADRYL and TYLENOL and ice. AE improved after stopping therapy. On 08-DEC-2010, the patient recovered. No further information is available.
Age: 14.0
Sex: F
Vaccine: PPV
Symptoms: Antibody test negative
Clinical narrative: This report was received from Pfizer, Inc. and was assigned manufacturer report number 2010164948 for PREVNAR 13. Information has been received from a physician concerning a 14 year old female patient who in approximately March 2009, "last spring", was vaccinated with a dose of PNEUMOVAX 23 (lot number not specified). On an unspecified date, the patient had low pneumococcal titers levels. It was unspecified if the patient sought medical attention. At the time of this report, the patient's outcome was unknown. It was not clear if the patient was given PREVNAR 13. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 69 year old male patient who on 06-DEC-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot # 667913/1021Z). On 06-DEC-2010 the patient experienced an adverse reaction at the injection site and a fever. The injection site was warm, reddened and swollen with an area of induration 6 cm in diameter. His temperature was 99.4. The patient reported the event to a physician's office. The doctor prescribed a steroid and an antibiotic. At the time of reporting, the patient did not recover from the adverse events. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Inflammation
Clinical narrative: Information has been received from a pharmacist concerning a "transplant patient" who on an unspecified date was vaccinated intramuscularly with 0.5ml PNEUMOVAX 23 (lot # not reported) for prophylaxis of pneumonia. Subsequently the patient experienced local redness and inflammation. It was unknown if this was the first dose of PNEUMOVAX 23. The patient had sought unspecified medical attention. At the time of reporting, the outcome was unknown. This is one of several reports received from the same source. Additional information is not expected.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 48 year old female patient with no pertinent medical history and no drug reactions/allergies, who on 30-NOV-2010 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (Lot # 667915/1111Z)) IM. Concomitant therapy included CLONOPIN, AMBIEN, cyclobenzaprine HCl, DEPAKOTE ER, SYNTHROID, TRUVADA, VIREAD, SUSTIVA (also reported as STUSTIVA), NEURONTIN, MOTRIN and prazosin. The nurse reported that on 02-DEC-2010, 48 hours after the vaccination, the patient developed a severe injection site reaction. The injection site became painfully red and swollen and spread to axilla and chest wall area. There were no lab diagnosis/studies performed. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. The nurse requested a lot check for this lot# due to adverse experiences. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 667915/1111Z were satisfactory. The lot met the requirements of the Center of Biologics Evaluation and Research and was released. This is one of two reports from the same source. Follow-up information has been received from the registered nurse who reported that the immunecompromised patient with no medical history no pre-existing allergies and no birth defects was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (Lot # 667915/1111Z) IM, on 30-NOV-2010 at 14:38. The nurse stated that on 02-DEC-2010, 48 hours after immunization the patient was seen and present with an erythema pain at the injection site and an exam was performed for the Doctor's patient that noted cellulitis axilla and spread to chest wall. The patient was prescribed with dicloxacillin 500mg for 5 days to the treatment of cellulitis. On 09-DEC-2010 the patient had recovered. The patient did not seek medical attention. No further information is available.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal chest pain
Clinical narrative: Information has been received from a registered nurse concerning a 48 year old female patient with no pertinent medical history and no drug reactions/allergies, who on 30-NOV-2010 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (Lot # 667915/1111Z)) IM. Concomitant therapy included CLONOPIN, AMBIEN, cyclobenzaprine HCl, DEPAKOTE ER, SYNTHROID, TRUVADA, VIREAD, SUSTIVA (also reported as STUSTIVA), NEURONTIN, MOTRIN and prazosin. The nurse reported that on 02-DEC-2010, 48 hours after the vaccination, the patient developed a severe injection site reaction. The injection site became painfully red and swollen and spread to axilla and chest wall area. There were no lab diagnosis/studies performed. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. The nurse requested a lot check for this lot# due to adverse experiences. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 667915/1111Z were satisfactory. The lot met the requirements of the Center of Biologics Evaluation and Research and was released. This is one of two reports from the same source. Follow-up information has been received from the registered nurse who reported that the immunecompromised patient with no medical history no pre-existing allergies and no birth defects was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (Lot # 667915/1111Z) IM, on 30-NOV-2010 at 14:38. The nurse stated that on 02-DEC-2010, 48 hours after immunization the patient was seen and present with an erythema pain at the injection site and an exam was performed for the Doctor's patient that noted cellulitis axilla and spread to chest wall. The patient was prescribed with dicloxacillin 500mg for 5 days to the treatment of cellulitis. On 09-DEC-2010 the patient had recovered. The patient did not seek medical attention. No further information is available.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Expired drug administered, Local reaction
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a male who on 29-OCT-2010 was intramuscularly vaccinated with a dose of expired PNEUMOVAX 23 (lot # 662842/1296X) in the right arm. Concomitant therapy included influenza virus vaccine (unspecified) in the left arm. Patient had unspecified local site reaction post vaccination. But during followup visit the patient had recovered. The patient sought unspecified medical attention. This is one of several reports received from the same source. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning an adult patient who on approximately 18-OCT-2010 ("this week") was vaccinated with a dose of PNEUMOVAX 23 (Lot # 665925/0932Z). On approximately 18-OCT-2010 the patient developed adverse reactions. Injection site reactions included swelling, erythema, and pain. The nurse requested a lot check. At the time of the report the outcome of the patient was unknown. A lot check has been initiated. 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 of Biologics Evaluation and Research and was released. This is one of several reports received from the same source. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Induration, Pain, Pain in extremity
Clinical narrative: Information has been received from a doctor's office staff concerning a 49 year old female with no drug allergy and no medical history who on 17-NOV-2010 was vaccinated IM with PNEUMOVAX 23, 0.5ml (lot # 667692/1110Z). Concomitant therapy included ADVAIR, aspirin, cephalexin, cyclobenzaprine HCl (MSD), gabapentin, hydrocodone, acetaminophen, multivitamin, naproxen, PORTIA and ezetimibe (+) simvastatin (MSD). Within an hour or 2 (17-NOV-2010) the patient experienced significant pain, redness, swelling and it hurt to move her arm. When the patient called the office on the next day she thought the symptoms were about the same as the night before. She also had a low grade temperature. Lab diagnostics studies were not performed. Treatment given for the vents included ice packs and antihistamine. The patient had sought medical attention by phone. At the time of reporting, the outcome was unknown. It was unknown if the patient received PNEUMOVAX 23 in the past. Additional information has been received from a physician's office concerning a 49 year old female with low back pain, ventral hernia, irregular menses, a family history of breast cancer (mother), osteoporosis and hypertension, and past history of cholecystectomy (1985) and vaginal delivery (1994). It was reported that the pt received a flu vaccine, split (manufacturer unknown) in October 2010 and that the patient had received a prior does of PNEUMOVAX 23 (no date provided). On 17NOV2010 pt received a dose of PNEUMOVAX 23 intramuscularly in the left arm. On 19NOV2010 the pt saw her physician for her reaction to PNEUMOVAX 23 which included significant pain, then swelling and redness. She had significant erythema and induration going down from the mid arm to upper forearm encompassing the elbow and down to wrist. She had good flexibility of the joint. Assessment was a nonvesicular rash. The physician marked the area with a pen and advised patient that the area should not get any larger. If worsened, the patient needed to be seen. The physician reported that the patient recovered on 26NOV2010 and that she had "received 1 prior dose of PNEUMOVAX 23 and she should not receive any more". This is one of several reports received from the same source. Additional information has been requested. All medical records will be provided upon request.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Swelling
Clinical narrative: Information has been received from a doctor's office staff concerning a 49 year old female with no drug allergy and no medical history who on 17-NOV-2010 was vaccinated IM with PNEUMOVAX 23, 0.5ml (lot # 667692/1110Z). Concomitant therapy included ADVAIR, aspirin, cephalexin, cyclobenzaprine HCl (MSD), gabapentin, hydrocodone, acetaminophen, multivitamin, naproxen, PORTIA and ezetimibe (+) simvastatin (MSD). Within an hour or 2 (17-NOV-2010) the patient experienced significant pain, redness, swelling and it hurt to move her arm. When the patient called the office on the next day she thought the symptoms were about the same as the night before. She also had a low grade temperature. Lab diagnostics studies were not performed. Treatment given for the vents included ice packs and antihistamine. The patient had sought medical attention by phone. At the time of reporting, the outcome was unknown. It was unknown if the patient received PNEUMOVAX 23 in the past. Additional information has been received from a physician's office concerning a 49 year old female with low back pain, ventral hernia, irregular menses, a family history of breast cancer (mother), osteoporosis and hypertension, and past history of cholecystectomy (1985) and vaginal delivery (1994). It was reported that the pt received a flu vaccine, split (manufacturer unknown) in October 2010 and that the patient had received a prior does of PNEUMOVAX 23 (no date provided). On 17NOV2010 pt received a dose of PNEUMOVAX 23 intramuscularly in the left arm. On 19NOV2010 the pt saw her physician for her reaction to PNEUMOVAX 23 which included significant pain, then swelling and redness. She had significant erythema and induration going down from the mid arm to upper forearm encompassing the elbow and down to wrist. She had good flexibility of the joint. Assessment was a nonvesicular rash. The physician marked the area with a pen and advised patient that the area should not get any larger. If worsened, the patient needed to be seen. The physician reported that the patient recovered on 26NOV2010 and that she had "received 1 prior dose of PNEUMOVAX 23 and she should not receive any more". This is one of several reports received from the same source. Additional information has been requested. All medical records will be provided upon request.
Sex: F
Vaccine: PPV
Symptoms: Anaphylactic reaction, Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot # not provided). It was reported that the patient developed an anaphylactic reaction which manifested as a rash on her arm. It was unknown if the patient sought medical attention. At the time of this report, the patient's outcome was unknown. No further information is available.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Body temperature increased, Chills, Erythema, Induration, Malaise
Clinical narrative: Information has been received from a physician concerning his 65 year old wife who on 27-SEP-2010 was vaccinated with a subcutaneously with a dose of PNEUMOVAX 23 (Lot # no reported). On the same day, the patient received a dose of flu vaccine (manufacturer unknown). The physician reported that on 27-SEP-2010 8 hours after the vaccination, his wife experienced chills and severe malaise. The next day, on 28-SEP-2010 there was induration to the elbow, red macular rash generalized and temperature 101.5F. She saw her physician and was treated with aspirin and BENADRYL. On 29-SEP-2010 the rash has faded, temperature was down but her arm was still hot, swollen and tender. The physician also reported that the patient received a dose of flu vaccine in the same arm there were not reactions noted around the flu shot. The patient sought medical attention. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Oedema peripheral, Rash generalised, Rash macular, Skin warm
Clinical narrative: Information has been received from a physician concerning his 65 year old wife who on 27-SEP-2010 was vaccinated with a subcutaneously with a dose of PNEUMOVAX 23 (Lot # no reported). On the same day, the patient received a dose of flu vaccine (manufacturer unknown). The physician reported that on 27-SEP-2010 8 hours after the vaccination, his wife experienced chills and severe malaise. The next day, on 28-SEP-2010 there was induration to the elbow, red macular rash generalized and temperature 101.5F. She saw her physician and was treated with aspirin and BENADRYL. On 29-SEP-2010 the rash has faded, temperature was down but her arm was still hot, swollen and tender. The physician also reported that the patient received a dose of flu vaccine in the same arm there were not reactions noted around the flu shot. The patient sought medical attention. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PPV
Symptoms: Wrong drug administered
Clinical narrative: This report was received from Pfizer and was assigned manufacturer report number 2011090133 concerning a 21 weeks female with relevant drug history unknown and relevant medical history unknown who on an unknown date was vaccinated with a dose of PNEUMOVAX 23 (lot # not reported) instead of PREVNAR through unknown route at 14:30 pm on unknown site Relevant drug history was unknown. Relevant medical history was unknown. Relevant concomitant medications were unknown. Vaccine given on the same day included poliovirus vaccine, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and Hib conj vaccine (unspecified carrier). Vaccines taken within the last four weeks were unknown. Relevant lab date was unknown. Conflicting information at the time of reporting, the patient was not taking PREVNAR and it was unknown if she was taking PNEUMOVAX 23. This was originally reported by consumer. All telephone attempts to obtain follow-up information had been unsuccessful. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Pyrexia
Clinical narrative: Information has been received from a physician concerning about seven patients who on an unspecified date were vaccinated with a dose of PNEUMOVAX 23 (Lot # 665904/0866Z, expiration date on 04-JUL-2011) (also reported as lot# "0868Z"). The physician reported that the patients developed fever the next day that lasted approximately 3 days. The physician stated that she had never seen so many adverse reactions with PNEUMOVAX 23 before. At the time of this report, the patient's outcome were unknown. The physician reported that the patients developed fever 38.5 degrees C - 39.0 degrees C and cellulitis within 12 hours of receiving vaccine. Fever lasted anywhere between 3 to 5 days. The physician did not provide any information on the duration of cellulitis. The injection site reaction extended from the area of the shot to the elbow and two patients were treated with antibiotics. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. A priority lot check has been initiated. Follow up information has been received from the physician who reported that one of the patients was a 45 year old male patient who on an unspecified date was vaccinated with the first dose of PNEUMOVAX 23 (Lot # 665904/0866Z, expiration date on 04-JUL-2011). The physician reported that the patient developed fever of 39C that lasted for 4-5 days and severe cellulitis which had extending form the shoulder to his elbow. The physician did not provide any information on the duration of cellulitis. At the time of the report, the outcome of the patient was not reported. A standard lot check investigation has been finalized. All in-process quality checks for the lot number (665904/0866Z) in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center of Biologics Evaluation and Research and was released. Follow up information from the physician concerning a 45 year old male (WT: 160, HT: 5' 11') patient with Ankylosing spondylitis who on 27-SEP-2010 was vaccinated with the first dose of dose of PNEUMOVAX 23 (Lot # 665904/0866Z, expiration date on 04-JUL-2011) IM on the right deltoid. Within 12 hours on 28-SEP-2010 the patient developed high fever up to 105, severe cellulitis type reached right upper extremity to the elbow and lasted 7 days. The patient was treated with LEVAQUIN and nonsteroidal anti-inflammatory drug (unspecified) (NSAIDS). This is one of several reports from the same source. No further information is available.
Age: 12.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Induration, Injection site induration, Injection site mass
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old female patient who on 15-SEP-2010 was vaccinated intramuscularly into the left deltoid with a 0.5 ml dose of PNEUMOVAX 23 (Lot # 665902/1426Y, Exp Date 02-JUL-2011). The nurse reported that on 16-SEP-2010, the patient's mother called stating that her daughter had a fever of 102F and swelling of the left arm. On 17-SEP-2010, the patient was seen at the office with swelling on her left arm from shoulder to left elbow. On 22-SEP-2010, the patient's mother called the doctor office stating that her daughter's swelling had decreased somewhat but the arm was rock hard. The nurse requested an investigation of the specific lot. This is one of several reports from the same source. A lot check has been initiated. 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 of Biologics Evaluation and Research and was released. Follow up information has been received from a registered nurse concerning the 12 year old female student with allergy to CECLOR who on 15-SEP-2010 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23. On 16-SEP-2010, the patient experienced febrile, swollen, hard, red and warm. The patient still hard lump at the injection site at the time of reporting. The outcome of other adverse events was reported as recovered. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Oedema peripheral, Pyrexia, Swelling
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old female patient who on 15-SEP-2010 was vaccinated intramuscularly into the left deltoid with a 0.5 ml dose of PNEUMOVAX 23 (Lot # 665902/1426Y, Exp Date 02-JUL-2011). The nurse reported that on 16-SEP-2010, the patient's mother called stating that her daughter had a fever of 102F and swelling of the left arm. On 17-SEP-2010, the patient was seen at the office with swelling on her left arm from shoulder to left elbow. On 22-SEP-2010, the patient's mother called the doctor office stating that her daughter's swelling had decreased somewhat but the arm was rock hard. The nurse requested an investigation of the specific lot. This is one of several reports from the same source. A lot check has been initiated. 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 of Biologics Evaluation and Research and was released. Follow up information has been received from a registered nurse concerning the 12 year old female student with allergy to CECLOR who on 15-SEP-2010 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23. On 16-SEP-2010, the patient experienced febrile, swollen, hard, red and warm. The patient still hard lump at the injection site at the time of reporting. The outcome of other adverse events was reported as recovered. Additional information is not expected.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Antibody test negative, No therapeutic response
Clinical narrative: This report was received from Pfizer Inc. and was assigned manufacturer report number 2011083177 and case # 11792512 concerning a 55 year old female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot #, expire date and route not reported). It was reported that the patient did not respond to the PNEUMOVAX 23, so it was being considered to use PREVNAR 13 instead. On an unspecified date, the patient had a specific antibody deficiency. It was unknown if the patient sought medical attention. At the time of the report, patient's outcome was unknown. This was originally reported by a physician. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Information has been received from a healthcare worker concerning a 68 year old female patient with no pertinent medical history and no known drug allergies who on 21-MAR-2011 was vaccinated with the first dose of PNEUMOVAX 23 (lot # 667914/1067Z, expire date 28-FEB-2012), 0.5 ml, intramuscularly. The healthcare worker reported that on 23-MAR-2011s, the patient developed a 2 cm area of redness and swelling at the injection site after administration of the first dose of PNEUMOVAX 23. The patient also experienced low grade fever, chills, and achiness. The healthcare worker mentioned that the patient was examined by the physician via office visit on 25-MAR-2011 and 01-APR-2011. No treatment was given to the patient. There were no laboratory diagnostics studies performed. On 01-APR-2011, the patient recovered. This is one of two reports received from the same source. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Nausea
Clinical narrative: Information has been received from a pharmacist concerning a 70 year old female patient with drug allergy to sulfa, codeine and neomycin cream who on 04-MAY-2011 was vaccinated IM with 0.5 ml PNEUMOVAX 23 (lot # 667915/1111Z, expiration date 02-MAR-2011). In May 2011, the patient developed redness and pain at the injection site as well as nausea. The pharmacist was not sure if the patient had previously received PNEUMOVAX 23 vaccine in the past. The patient sought medical attention by calling the pharmacist. No treatment was given to the patient. No lab tests were performed. At the time of reporting, the patient had not recovered from the adverse events. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a healthcare worker concerning a male patient who on unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot # 667914/1067Z, expire date 28-FEB-2012, route not reported). The healthcare worker reported that on an unspecified date, the patient developed redness and swelling at the injection site after administration of PNEUMOVAX 23. It was unknown if the patient sought medical attention. At the time of the report patient's outcome was unknown. This is one of two reports received from the same source. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a healthcare worker (office manager) concerning a 72 year old female patient with no drug reactions or allergies and no pertinent medical history who on 09-MAY-2011 was vaccinated IM with a dose of PNEUMOVAX 23 (lot# 668009/1174Z, exp. 10-MAR-2011). Concomitant therapy included NEXIUM, LIPITOR, DYAZIDE and ECOTRIN. On 10-MAY-2011 the patient developed severe swelling, redness and pain in her right arm that extended to her elbow. The patient was seen in the office on 10-MAY-2011 and then again on 11-MAY-2011. No laboratory diagnostics studies were performed. The patient was prescribed and unspecified dose of AUGMENTIN. At the time of reporting, the patient was recovering. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: Information has been received from a pharmacy student concerning a male patient who on an unspecified date was vaccinated SQ with a dose of PNEUMOVAX 23 (lot number not provided). The pharmacy student reported that the patient developed a reaction. The pharmacy student did not known the nature of the reaction. The patient sought unspecified medical attention. It was unspecified if any lab diagnostic studies were performed or if any treatment was given for the adverse event. At the time of the report, the patient's outcome was unknown. Additional information has been requested.