chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous
Clinical narrative: Information has been received from a registered nurse concerning a 62 year old female patient with penicillin G allergy and no pertinent medical history who on 08-OCT-2010 was vaccinated IM with a 0.5ml dose of PNEUMOVAX 23 (lot # 667418/0978Z). There was no concomitant medication. On 08-OCT-2010 the patient experienced a cellulitis like reaction at the injection site after receiving PNEUMOVAX 23. The patient experienced severe pain and developed red spots on the site of injection to the left side of her chest. She had significant fatigue and loss of appetite. At the time of reporting, the patient was recovering. The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who on an unspecified date was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (Lot # 665902/1426Y) IM. The patient experienced redness and swelling at the injection site after receiving the dose of PNEUMOVAX 23. The patient sought unspecified medical attention. At the time of the report, the patient was recovering. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Information has been received from a registered nurse concerning a patient that was over age 65 who on an unspecified date was vaccinated with the first dose of PNEUMOVAX 23 (Lot# either 663889/0632Y or 665924/0930Z). It was reported that on an unspecified date, the patient experienced a local site reaction (redness, swelling, and pain). The nurse reported that the patient received either dexamethasone (MSD) or dexamethasone (manufacturer unknown) as treatment (thought to be an allergic reaction). On an unspecified date, the patient recovered. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. The health care professional contacted during telephone follow up could not supply the following information: patient names, dates of birth, dates of vaccination, lot number and dates of events. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Infection, Injection site infection
Clinical narrative: Information has been received from a pharmacist concerning a patient who "recently", in 2010 was vaccinated with PNEUMOVAX 23 (lot # not reported). Subsequently, in 2010 the patient experienced an infection at the injection site with "infection below the elbow to the forearm". The patient sought unknown medical attention. The patient's outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Headache, Nausea, Pyrexia, Rash, Vomiting
Clinical narrative: Information has been received from a pharmacist concerning an over 65 year old patient who on 26-OCT-2010 was vaccinated with single injection of PNEUMOVAX 23 (lot# 667418/0978Z). Subsequently the patients experienced fever, rash, headache, nausea and vomiting. The patients experienced these side effects for 3 to 4 days after the initial injection. This is one of several reports received from the same source. 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. All attempts to obtain further information were unsuccessful. This is an amended report. This report is split one more time to capture the other over 65 year old patient. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Injection site cellulitis, Injection site erythema, Injection site lymphadenopathy, Injection site swelling
Clinical narrative: Information has been received from a registered nurse via a telephone call and a physician concerning a 70 year old alert and oriented female with no known allergies and chronic rhinitis who on 11-OCT-2004 at 14:00 PM was vaccinated in her left arm with PNEUMOVAX 23. On 11-OCT-2004 at 14:00 PM, the patient was also vaccinated with the AFLURIA in her right arm. Concomitant therapy included ATARAX, ZESTORETIC and PREMARIN. On 12-OCT-2004 at 14:30, the patient reported a red, hot and swollen five inch area at her left arm injection site where she received the PNEUMOVAX 23. It was reported the five inch area at the "pneumonia vaccine" injection site was getting bigger. The patient denied pain and fever. The patient was instructed to use ice packs, take TYLENOL and call if she was not better within twenty-four hours. On 13-OCT-2004 at 8:07 AM, the patient called the registered nurse and reported she was faint and nauseous the night before. She was using ice packs and acetaminophen as recommended. On 13-OCT-2004, 08:45 AM the patient was seen by her physician. At the site of injection there was no induration and no warmth. The patient's diagnoses were left upper limb superficial cellulitis and lymphadenopathy site of injection. The patient was treated with KEFLEX for five days and was instructed to call her physician if her signs and symptoms were not improved in forty-eight hours. At the time of the report, the patient's outcome was not reported. All available medical records will be provided upon request. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Nausea
Clinical narrative: Information has been received from a registered nurse via a telephone call and a physician concerning a 70 year old alert and oriented female with no known allergies and chronic rhinitis who on 11-OCT-2004 at 14:00 PM was vaccinated in her left arm with PNEUMOVAX 23. On 11-OCT-2004 at 14:00 PM, the patient was also vaccinated with the AFLURIA in her right arm. Concomitant therapy included ATARAX, ZESTORETIC and PREMARIN. On 12-OCT-2004 at 14:30, the patient reported a red, hot and swollen five inch area at her left arm injection site where she received the PNEUMOVAX 23. It was reported the five inch area at the "pneumonia vaccine" injection site was getting bigger. The patient denied pain and fever. The patient was instructed to use ice packs, take TYLENOL and call if she was not better within twenty-four hours. On 13-OCT-2004 at 8:07 AM, the patient called the registered nurse and reported she was faint and nauseous the night before. She was using ice packs and acetaminophen as recommended. On 13-OCT-2004, 08:45 AM the patient was seen by her physician. At the site of injection there was no induration and no warmth. The patient's diagnoses were left upper limb superficial cellulitis and lymphadenopathy site of injection. The patient was treated with KEFLEX for five days and was instructed to call her physician if her signs and symptoms were not improved in forty-eight hours. At the time of the report, the patient's outcome was not reported. All available medical records will be provided upon request. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Oedema, Rash
Clinical narrative: Information has been received from a nurse concerning a male who on 06-OCT-2010 was vaccinated with PNEUMOVAX 23 (lot # 665924/0930Z, expiration date 17-JUL-2011). Subsequently the patient developed adverse events of 3 to 4 inch swelling at injection site, rash and edema. The patient's 3 to 4 inch swelling at injection site, rash and edema persisted. The patient sought unspecified medical attention. The nurse reported that for two patients that vaccination was their first vaccination of PNEUMOVAX 23. It was also reported that the route of vaccination was IM for one patient and SC for two patients. The nurse requested a lot check. A lot check was initiated. This is one of several reports received from the same source. Additional information has been requested. 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 an amended report. Vaccinated at: unknown and vaccinated with: unknown were added in therapy screen.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Oedema, Rash
Clinical narrative: Information has been received from a nurse concerning a female who on 06-OCT-2010 was vaccinated with PNEUMOVAX 23 lot # 665924/0930Z, expiration date 17-JUL-2011. Subsequently the patient developed adverse events of 3 to 4 inch swelling at injection site, rash and edema. The patient's 3 to 4 inch swelling at injection site, rash and edema persisted. The patient sought unspecified medical attention. The nurse reported that for two patients that vaccination was their first vaccination of PNEUMOVAX 23. It was also reported that the route of vaccination was IM for one patient and SC for two patients. The nurse requested a lot check. A lot check was initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number (665924/0930Z) 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: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who on an unspecified date was vaccinated with a 0.5 ml dose PNEUMOVAX 23 (Lot No. 665707/1407Y) IM. the patient experienced redness and swelling at the injection site after receiving the dose of PNEUMOVAX 23. The patient sought unspecified medical attention. At the time of the report the patient was recovering. This is one of several reports from the same source. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Rash macular, Urticaria
Clinical narrative: Information has been received from a Registered Nurse concerning a 47 year old female patient with seasonal allergies and allergy to codeine who on 21-SEP-2010 was vaccinated in the left deltoid with a 0.5 ml dose of PNEUMOVAX 23 (Lot# 665707/1407Y) (Expiration date: 12-JUN-2011). On 21-SEP-2010, the patient also received a dose of BOOSTRIX in the left deltoid and a dose of FLUZONE in the right deltoid. The nurse reported that on September 2010, the patient experienced soreness in left arm with hives, swelling and redness. The patient reported that she took BENADRYL. There were no laboratory tests or diagnostic studies performed. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Follow up information has been received from a registered nurse. It was reported that the patient with allergy to azithromycin (oral), LEVAQUIN, LIPITOR and penicillin was vaccinated IM in the left deltoid with the first dose of PNEUMOVAX 23 (Lot# 665707/1407Y) on 21-SEP-2010. On 21-SEP-2010, the patient also received the first dose of BOOSTRIX (lot number AC52B051AB) IM in the left deltoid and the first dose of FLUZONE (lot number UH214AC) IM in the right deltoid. There was no illness at the time of vaccination. The registered nurse reported that the patient stopped by the office on 27-SEP-2010 and stated she had a reaction to her PNEUMOVAX 23 shot. The patient's arm got red, she had swelling to upper arm and hives to arm. The patient took BENADRYL. No laboratory tests were performed. At the time of the report the patient's outcome was resolving (also reported as recovered). The nurse reported that the upper arm still had a fine rash and blotched to arm. No further information is expected.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Information has been received from a Registered Nurse concerning a 74 year old female patient who on 11-OCT-2010 was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (Lot# 667445/0993Z) (Expiration date: 05-JAN-2012). The nurse reported that on 11-OCT-2010, the patient's upper left arm was swollen, red, warm and tender. The nurse also stated that the patient reported body aches. At the time of the report, the patient was recovering. The patient sought unspecified medical attention. Follow up information has been received from a physician concerning the 74 year old retired female patient with emphysema, constipation, neuropathy, atrial fibrillation, gastrooesophageal reflux disease, hypothyroidism, iron deficiency, anaemia and allergy to codeine, MUCINEX and VANEX-LA and no illness at the time of vaccination on 08-MAR-2010 was vaccinated IM with the first dose of PNEUMOVAX 23 (Lot # and route not reported) and on 11-OCT-2010 at 10:25 was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (Lot# 667445/0993Z) (Expiration date: 05-JAN-2012). It was reported that on 12-OCT-2010, in the morning the patient experienced injection side red on her left upper arm, warm, and swollen, low grade fever and body aches. On approximately 13-OCT-2010 the patient had recovered. Additional information is not expected.
Age: 15.0
Sex: F
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 15 year old 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 approximately 17-SEP-2010, one day post-vaccination, the patient developed high fever of 102F and swelling of the left arm from shoulder to elbow. On 17-SEP-2010 the patient was seen at the doctor's office. At the time of the report, the outcome of the patient was not reported. The nurse reported 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 for Biologics Evaluation and Research and was released. Follow up information had been received from a registered nurse concerning a 15 year old female patient who on 15-SEP-2010 was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (Lot # 665902/1426Y, Exp Date 02-JUL-2011). On 16-SEP-2010, the patient experienced febrile, swollen, hard, red and warm. On an unspecified date, the patient recovered. No other information reported. Additional information not expected.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Skin warm, Wrong drug administered
Clinical narrative: Information has been received from a consumer concerning an 84 year old female patient with arthritis and no known drug reactions or allergies who on 22-SEP-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 665300/1314Y) injection instead of "flu shot". It was reported that the patient upper arm became red, hot and swollen on 23-SEP-2010. The patient did not seek medical attention. At the time of this report, the outcome of the patient was unknown. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a nurse concerning a patient who in approximately September 2010 ("fall of 2010"), was vaccinated with one dose of 0.5 ml PNEUMOVAX 23 (lot # not reported). In approximately September 2010 ("within that week which took place in the fall of 2010"), the patient developed cellulitis like reaction at the injection site after getting the vaccine. The patient was not concerned about it. No treatment was given to the patient. No lab tests were performed. Subsequently, the patient recovered from the adverse event. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Rash
Clinical narrative: Information has been received from an office manager concerning a patient over 65 years of age, who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number not specified). It was reported that the patient experienced adverse reactions on an unspecified date after receiving the PNEUMOVAX 23. The patient complained of redness and little bumps. The patient sought unspecified medical attention. It was given Y-cold compress as a treatment for the adverse event. It was unspecified if the any lab diagnostic studies were performed. At the time of the report, the patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Pain, Pain of skin, Pyrexia, Rash papular
Clinical narrative: Information has been received from a physician concerning a 56 year old female who on 10-SEP-2010 was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (Lot # 663888/0627Y, exp date 10-OCT-2010). The physician reported that on 10-SEP-2010, the patient experienced that the effected arm had multiple raise areas, fever, body ache, skin hurts and she felt like she had the flu. On an unspecified date, the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 1.36
Sex: M
Vaccine: HIBV, PPV
Symptoms: Pyrexia, Wrong drug administered
Clinical narrative: Information has been received from a nurse concerning a 16 month old male with watching head circumference and no drug allergy who on 25-FEB-2011 was vaccinated intramuscularly with a dose of 0.5ml PNEUMOVAX 23 instead of PREVNAR. Second suspect therapy included PEDVAXHIB injection on the same day (dose, route and lot # not reported). Concomitant therapy included vitamins with fluoride. The patient had received three doses of PREVENAR prior to receiving PNEUMOVAX 23. The patient developed a fever of 101F in the evening that the patient received PNEUMOVAX 23 and PEDVAXHIB. The patient did not seek medical attention. No lab diagnostics study was performed. At the time of reporting, the patient recovered from fever. Follow-up information has been received from an office manager who reported that the wrong drug administration was not due to product confusion. The office manager reported the nurse did not remember exactly how she gave the wrong vaccine, but she did remember that it was not due to product confusion. No further information is available.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Expired drug administered, Mobility decreased, Pain, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a 66 year old female patient with hypertension and hyperlipidaemia who on 23-SEP-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot# 667912/0933Z, exp date 25-FEB-2010) into her left deltoid. On 25-SEP-2010 the patient called with redness, swelling, can't move her arm, fever chills and pain. At the time of this report, the patient had not recovered from redness, swelling, can't move her arm, fever chills and pain. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Information has been received from a pharmacist concerning a 66 year old female patient with hypertension and hyperlipidaemia who on 23-SEP-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot# 667912/0933Z, exp date 25-FEB-2010) into her left deltoid. On 25-SEP-2010 the patient called with redness, swelling, can't move her arm, fever chills and pain. At the time of this report, the patient had not recovered from redness, swelling, can't move her arm, fever chills and pain. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Information has been received from a pharmacy tech concerning a female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot number 665903/1427Y) from a multi dose vial. After vaccination the patient had red swollen feverish injection site reactions with temperatures to 103 degrees F and feeling achy. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received 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 665903/1427Y were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Oedema peripheral
Clinical narrative: Information has been received from a registered dietician concerning a 78 year old female inpatient with hypertension, arthritis and leaky valve of heart, drug reaction/allergies to penicillin and naproxen who in May 2008, "3 years ago", was vaccinated with a dose of PNEUMOVAX 23 (lot number not reported) while in the hospital for an unrelated condition. Concomitant therapy included TOPROL XL TABLETS, DYAZIDE and PREMARIN. In May 2008, "3 years ago", the patient's arm immediately became swollen, "it was very significant." She did not know how long the swelling lasted but denied any difficulty breathing. The patient was given cold packs only due to other medical problems at that time. On an unspecified date, the patient recovered from her arm immediately became swollen. The patient sought medical attention while an inpatient at the hospital. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: Information has been received from a Doctor of Pharmacy concerning an approximately 51 year old female patient with no pertinent medical history and no drug reactions or allergies who in 1988 was vaccinated with the first dose of PNEUMOVAX 23, intramuscularly (lot number and dose not reported) with no adverse event reported. In 1996, the patient was vaccinated with the second dose of PNEUMOVAX 23, intramuscularly (lot number and dose not reported). When the patient got her second dose, in 1996, the patient had a local reaction. Also, it was reported that the patient had swelling and redness that last a few days. There were no other adverse events to report. It was unknown if the patient sought medical attention. No lab diagnostics studies were performed. At the time of the report, the patient had recovered in 1996. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site vesicles, Injection site warmth
Clinical narrative: Information has been received from a licensed practical nurse concerning a 73 year old female patient who on 22-SEP-2010 was vaccinated with a first 0.5 ml dose of PNEUMOVAX 23 (Lot No. 665707/1407Y). On 22-SEP-2010, within 2-3 hours after receiving the PNEUMOVAX 23 injection, the patient experienced pain and redness at the injection site. The patient was seen in office on 23-SEP-2010 and on exam the area of her right arm from elbow to shoulder was crimson red with several small blisters, fever to touch, extremely painful with nausea. Diagnosis was cellulitis, treated with AUGMENTIN 875mg twice a day for 14 days. She saw the doctor again on 24-SEP-2010, and the area was less swollen, no fever, still had pain in the medial side of right upper arm radiating into shoulder. Patient thought there was some improvement. She did not receive PNEUMOVAX 23 in the past. At the time of the report, the patient was recovering. This is one of several reports from the same source. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Nausea
Clinical narrative: Information has been received from a licensed practical nurse concerning a 73 year old female patient who on 22-SEP-2010 was vaccinated with a first 0.5 ml dose of PNEUMOVAX 23 (Lot No. 665707/1407Y). On 22-SEP-2010, within 2-3 hours after receiving the PNEUMOVAX 23 injection, the patient experienced pain and redness at the injection site. The patient was seen in office on 23-SEP-2010 and on exam the area of her right arm from elbow to shoulder was crimson red with several small blisters, fever to touch, extremely painful with nausea. Diagnosis was cellulitis, treated with AUGMENTIN 875mg twice a day for 14 days. She saw the doctor again on 24-SEP-2010, and the area was less swollen, no fever, still had pain in the medial side of right upper arm radiating into shoulder. Patient thought there was some improvement. She did not receive PNEUMOVAX 23 in the past. At the time of the report, the patient was recovering. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site nodule
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who on 11-MAY-2011 was vaccinated with a dose of PNEUMOVAX 23 (lot number 663209/1157X, expiry on 08-MAR-2012). On 12-MAY-2011, while on PNEUMOVAX 23, the patient had a large baseball-sized knot around the injection site. The nurse practitioner advised that this was not an allergic reaction. It was also reported that therapy was discontinued on 12-MAY-2011. The patient's a large baseball-sized knot around the injection site persisted. The patient sought unspecified medical attention. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Information has been received from an office manager concerning a 65 year old male patient, with no pertinent medical history, no drug reactions or allergies reported, who on 28-APR-2011 was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (Lot #: 668009/1174Z, Exp: 10-MAR-2011) (Dose not reported). Concomitant therapy included LIPITOR, PLAVIX and lisinopril. The office manager reported that on 28-APR-2011 the patient developed a rash two inches below the injection site after receiving PNEUMOVAX 23. On 29-APR-2011, the patient was seen in the office and prescribed and unspecified dose of AUGMENTIN. No lab/diagnostic studies were performed. There were no other adverse events to report. At the time of the report, the patient was still recovering. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a office manager concerning a 71 year old male patient with hyperlipidaemia and with no drug reactions or allergies who on 15-MAR-2005 was vaccinated intramuscularly with the first dose of PNEUMOVAX 23 (lot # and dose not reported). On 12-MAY-2011 the patient was vaccinated intramuscularly with the second dose of PNEUMOVAX 23 (lot # 668008/1157Z, expiration: 08-MAR-2012) (dose not reported). Concomitant therapy included LIPITOR, testosterone gel, TRICOR and finasteride (MSD). The office manager reported that after receiving PNEUMOVAX 23 on 12-MAY-2011, the patient woke up in the morning of 13-MAY-2011 with redness, pain, rash and swelling below the injection site, on his right upper arm. "Steroid and antibiotic" were given for the adverse events. The patient sought medical attention by office visit. There were no lab diagnostics studies performed. At the time of reporting, the patient's status was unknown. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: PPV, TTOX
Symptoms: Erythema, Injection site rash, Malaise, Myalgia, Oedema peripheral
Clinical narrative: Information has been received from a licensed practical nurse and a nurse practitioner, concerning a 32 year old male patient with multiple sclerosis and no drug reactions or allergies reported, who on 11-MAY-2011 was vaccinated intramuscularly in the right deltoid, with a 0.5 ml dose of PNEUMOVAX 23 (Lot #: 668008/1157Z) (It was unknown if it was the first or the second dose). Concomitant vaccination included: a tetanus vaccine (manufacturer unknown) in his left arm. Concomitant therapy included REBIF, 44mcg in 0.5 ml subcutaneous syringe 1/2 ml, 3 times per week and oxycodone/acetaminophen, one 5mg/325 as needed. Licensed Practical Nurse reported that patient developed a reaction to the PNEUMOVAX 23. Nurse practitioner reported that on 12-MAY-2011, the patient noted that his right arm was "red, swollen, and painful to touch'. He had a rash at the injection site that continued to spread over the next few days. Nurse also reported that patient's temperature was 102.6 F up to 103 F and that he had muscle aches and malaise. She stated that patient also experienced discomfort with movement of his right arm. Nurse reported that the fever continued into 13-MAY-2011, and on 14-MAY-2011 patient was feeling better. His fever had subsided and his arm pain improved. His rash, however, had become worse. TYLENOL and STERAPRED  DS 10 mg tab in a dose pack for 6 days, were given as treatment for the events. No lab/diagnostic studies were performed. Patient sought medical attention through office visit. At the time of the report the patient was recovering. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: PPV, TTOX
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse and a nurse practitioner, concerning a 32 year old male patient with multiple sclerosis and no drug reactions or allergies reported, who on 11-MAY-2011 was vaccinated intramuscularly in the right deltoid, with a 0.5 ml dose of PNEUMOVAX 23 (Lot #: 668008/1157Z) (It was unknown if it was the first or the second dose). Concomitant vaccination included: a tetanus vaccine (manufacturer unknown) in his left arm. Concomitant therapy included REBIF, 44mcg in 0.5 ml subcutaneous syringe 1/2 ml, 3 times per week and oxycodone/acetaminophen, one 5mg/325 as needed. Licensed Practical Nurse reported that patient developed a reaction to the PNEUMOVAX 23. Nurse practitioner reported that on 12-MAY-2011, the patient noted that his right arm was "red, swollen, and painful to touch'. He had a rash at the injection site that continued to spread over the next few days. Nurse also reported that patient's temperature was 102.6 F up to 103 F and that he had muscle aches and malaise. She stated that patient also experienced discomfort with movement of his right arm. Nurse reported that the fever continued into 13-MAY-2011, and on 14-MAY-2011 patient was feeling better. His fever had subsided and his arm pain improved. His rash, however, had become worse. TYLENOL and STERAPRED  DS 10 mg tab in a dose pack for 6 days, were given as treatment for the events. No lab/diagnostic studies were performed. Patient sought medical attention through office visit. At the time of the report the patient was recovering. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pain
Clinical narrative: Information has been received from a female consumer reporting on herself who on an unknown date was vaccinated with a dose of PNEUMOVAX 23 (manufacturer unknown) and "shortly after receiving the vaccine" she experienced her arm to swell and she felt aches and pain. It was unspecified if the consumer sought medical attention. At the time of the report, the consumer's outcome was unknown.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Myosclerosis, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Information has been received from a registered nurse concerning his physician who "back a few years ago" was vaccinated PNEUMOVAX 23. Subsequently the physician experienced same reaction as the nurse has experienced. The nurse reported that on 20-SEP-2010 at 11:00 AM he was vaccinated subcutaneously in his right arm with 0.5 ml PNEUMOVAX 23 (lot# 665707/1407Y). On the same day, a few hours later, his right arm was very stiff, painful, swollen and warm to the touch. He stated "it was almost like I had compartment syndrome". He stated he saw his physician this morning. He was advised to take two ibuprofen and apply ice. He stated his swelling went down 30% in the morning of 21-SEP-2010. There was no laboratory test performed. At the time of the report, his muscle was edematous and hard. At the time of this report, the physician's status was not reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 33 year old female patient who on 18-MAY-2011 was vaccinated intramuscularly in the left arm with a dose of PNEUMOVAX 23 (lot # 668008/1157Z), expiration date 08-MAR-2012. The physician reported that on 18-MAY-2011 and within a few hours the patient developed an injection site reaction. The injection site reaction was described as a swollen, warm and painful (sensitive to touch) area from the top of the arm to the elbow. It was unclear at the time of the call if the patient had received a previous vaccination with PNEUMOVAX 23. The physician also mentioned during the call that he had past patients (unspecified names, number and dates) that had not developed pneumococcal immunity after receiving PREVNAR. Treatment given for the adverse events included prednisone and arm soaks. Laboratory diagnostics studies were not performed. at the time of the report, the patient had not recovered. It was reported that the patient sought medical attention by office visit. This is one of two reports from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased
Clinical narrative: Information has been received from a Nurse Practitioner (N.P.) concerning a female who on 22-SEP-2010 was vaccinated with a dose of PNEUMOVAX 23. On 23-SEP-2010 (also reported as 22-SEP-2010), the patient could not move her arm (side not specified). At the time of the report, the outcome was unknown. The patient sought an unknown medical attention. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 20 year old female who on 16-MAR-2011 was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (lot#668008/1157Z; exp date: 08-MAR-2012) in left arm. On an unknown date ("within an unspecified time frame"), the patient developed an injection site reaction. The injection site reaction was described as a swollen, warm and painful (sensitive to touch) area from the top of the arm to the elbow. The patient was treated with "soaks", BENADRYL and prednisone. It was unclear if the patient had received a previous vaccination with PNEUMOVAX 23. The patient returned to the office for follow up on 17-MAR-2011 and 18-MAR-2011. There was no lab diagnostics studies performed. At the time of the report, the patient had recovered from her adverse events. The patient sought medical attention via office visit. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Rash
Clinical narrative: Information has been received from an office manager concerning a patient who was in 30's and who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number not specified). It was reported that the patient experienced adverse reactions on an unspecified date after receiving the PNEUMOVAX 23. The patient complained of redness and little bumps. The patient sought unspecified medical attention. It was given Y-cold compress as a treatment for the adverse event. It was unspecified if the any lab diagnostic studies were performed. At the time of the report, the patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea
Clinical narrative: Information has been received from a pharmacy student concerning a 57 year old female who in October 2010, was vaccinated with a dose of PNEUMOVAX 23 (dose and route not reported, reported lot# was invalid) and shortly after developed shortness of breath. The patient saw physician. At the time of reporting, the outcome was unknown. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a registered pharmacist concerning an actually 78 year old female patient with hypertension, allergy to LEVAQUIN, cephalexin and sulfonamides who on 01-JUL-2005 was vaccinated with the second dose of PNEUMOVAX 23 (Lot# and expiration date not reported). Concomitant therapy included ZOLOFT. Pharmacist reported that the patient experienced left arm swelling after administration of her second dose of PNEUMOVAX 23. The patient sought medical attention through an office visit. It was reported that the patient was treated with unspecified medication by doctor. At the time of reporting the patient had recovered on an unspecified date. Follow-up information was received indicating that there were no records. No further information is available.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Information has been received from a healthcare worker concerning an 84 year old female patient with no pertinent medical history and no known drug reactions/allergies, who on 28-MAR-2011 was vaccinated IM with a 0.5ml dose of PNEUMOVAX 23 (lot number 668008/1157Z). There was no concomitant medication. It was reported that on 30-MAR-2011 the patient experienced throbbing sensation in her arm where the PNEUMOVAX 23 was given. The patient's arm was also red and warm. It was reported that physician evaluated the patient and recommended cold compress and the patient prescribed ZYRTEC. No lab diagnostic test were performed. It was reported that the patient recovered after 2 weeks (recovered 13-APR-2011). This is one of several reports from the same source. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a 23 year old female medical assistant (who was also the patient) who on an unknown date was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (dose and lot # were not reported). The medical assistant reported that on an unspecified date she experienced swelling around the injection site and the area was painful for about a week and a half. The patient saw a nurse practitioner. The self therapy with MOTRIN and ice and movement exercises were given for the adverse events. At the time of reporting, the patient had recovered. The patient did not seek medical attention. No further information is available.
Age: 42.0
Sex: F
Vaccine: PPV, UNK
Symptoms: Chest pain, Dyspnoea, Erythema, Oedema peripheral
Clinical narrative: Information has been received from a Physician assistant concerning a 42 year old female patient with cardiovascular disease and smoker who on 17-MAR-2011, was vaccinated with PNEUMOVAX 23 (route, expiration date and lot number not reported). Concomitant therapy including metformin (manufacturer unknown), lisinopril (manufacturer unknown), lovastatin (manufacturer unknown), vitamins (unspecified), Lactobacillus acidophilus, ranitidine and PREVACID. At the same time, the patient was given diphtheria toxoid (+) paratyphoid A vaccine (+) paratyphoid B vaccine (+) tetanus toxoid (+) typhoid vaccine inactivated (manufacturer unknown) in the opposite arm. On an unknown date, the patient experienced a red swollen arm, pain across the chest and shortness of breath. The patient received as treatment for the event BENADRYL. The patient sought unspecified medical attention. At the time of the report the patient was recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 72 year old female patient, who on 05-APR-2011 was vaccinated with a dose of PNEUMOVAX 23, (lot#/667915/1111Z, expiration date: 02-MAR-2012), 0.5 ml, subcutaneously. On 06-APR-2011, the patient experienced injection site redness down her arm to the elbow, with pain and swelling. The patient sought unspecified medical attention. BENADRYL was given for the treatment of adverse event. At the time of the report, the patient was recovering. Follow-up information has been received from the nurse, concerning the 58 (previously reported as 72) year old, female patient, with allergy to sulfa, nabumetone and codeine, and who on 06-APR-2011 (previously reported as 05-APR-2011) at 15:15, was vaccinated in the left deltoid with the first dose of PNEUMOVAX 23, (lot#/667915/1111Z). Nurse reported that on 06-APR-2011, patient developed a knot on arm, pain, swelling and redness. Patient sought medical attention through emergency room/doctor visit. At the time of the report, the patient had recovered from knot on arm, pain, swelling and redness. No further information is available.
Age: 58.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Information has been received from a Registered Pharmacist (R.Ph.) concerning a 58 year old female with chronic obstructive pulmonary disease who on 22-SEP-2010 was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (Lot#663889/0632Y; Exp:12-Nov-2010). Concomitant therapy included influenza virus vaccine (unspecified) (manufacturer unknown). On 23-SEP-2010 the patient was in the pharmacy complaining of warmth, swelling, and pain around the injection site and traveling toward the shoulder of her left arm. Pharmacist put the patient on the phone who stated she got the PNEUMOVAX 23 every 5 years, and had been since the vaccine was first released. There was no lab diagnostics studies performed. The patient said she has been putting a compress on the swelling. At the time of the report, the patient has not been recovered from these adverse events. Follow-up information was received from a Registered Pharmacist concerning a 58 year old female with no illness at time of vaccination, who at 3:00 PM on 22-SEP-2010 was vaccinated with a second dose of PNEUMOVAX 23 (Lot#663889/0632Y) in the deltoid. This was a revaccination. The patient experienced sore arm on 22-SEP-2010 at 3:00 PM. It resolved itself in 2 days. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a "over 50" year old female consumer reporting on herself who on 30-MAR-2011, was vaccinated with a dose of PNEUMOVAX 23. On 30-MAR-2011, the patient experienced injection site swelling "below". The injection site that was on "the face of the arm and then rotated around the arm and was hot and painful". By Monday (04-APR-2011), it had subsided. Also, it was reported that then Wednesday through Saturday she had a fever of "100 degrees". At the time of the report, the patient outcome was unknown. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Abasia, Asthenia, Back pain, Dark circles under eyes, Dysstasia
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: 63.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Eyes sunken, Flushing, Grip strength decreased, Headache
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.