chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Respiratory rate increased
Clinical narrative: Information has been received from a pharmacy student concerning a 28 year old female patient who on 28-AUG-2009 was vaccinated with a dose of PNEMUOVAX 23 intravenously. There were no immediate adverse effects noted when the vaccine was received. Subsequently, later the patient developed an increased temperature and an increased respiratory rate. Medical attention was sought, the patient had an office visit. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Nausea, Oedema peripheral, Pain, Urticaria
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient who on an unspecified date was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (Lot # 662842/1296X). On an unknown date the patient experienced nausea, malaise, aching, an arm swollen to 2x its normal size and generalized hives. The patient sought unspecified medical attention. At the time of the report, the outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Information has been received from a medical assistant concerning a male patient who in 2004 was vaccinated with his first dose of PNEUMOVAX 23, and on 30-AUG-2009 he received a second 0.5ml dose (lot # 662840/1577X) SC in the right deltoid. The patient's relevant medical history and relevant past drug history were unknown. On 30-AUG-2009, after the vaccination, the patient had redness, hives and itching with local traveling at injection site. It was unknown if a similar reaction occurred with the 2004 administration of PNEUMOVAX 23. It was unknown if any lab tests were performed. As of 30-AUG-2009, it was unknown if the patient would receive another dose of PNEUMOVAX 23. The patient was currently in with the doctor receiving medical attention and the outcome of the events was unknown. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pain, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a 51 year old female patient with erythromycin allergy and no pertinent medical history who on 09-SEP-2009 was vaccinated with a 0.5mL dose of PNEUMOVAX 23 (lot# 662905/1162X) intramuscularly. On 09-SEP-2009 the patient developed a red circle 2-3 inches wide at the side of injection after vaccination. By 11-SEP-2009 the area had expanded to 10 inches wide. She was also experiencing pain in the arm, general achiness and fever. The patient contacted the pharmacist for medical attention. There were no lab diagnostic studies performed. At the time of the report, the patient had not recovered. Additional information has been requested. This is one of several reports from the same source.
Sex: U
Vaccine: PPV
Symptoms: Oedema peripheral, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a HIV patient who was vaccinated with PNEUMOVAX 23 and had more of a swollen arm and fever than normal. The patient had sought unknown medical attention. At the time of report the patient's status was unknown. This is one of several reports from the same source. On 23-SEP-2009 all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Malaise, Nausea, Oedema peripheral, Pain
Clinical narrative: Information has been received from a physician concerning a 19 year old female patient who on an unspecified date was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (Lot # 662842/1296X). On an unknown date the patient experienced nausea, malaise, aching, an arm swollen to 2x its normal size, fever and headache. The patient sought unspecified medical attention. At the time of the report, the outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a 19 year old female patient who on an unspecified date was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (Lot # 662842/1296X). On an unknown date the patient experienced nausea, malaise, aching, an arm swollen to 2x its normal size, fever and headache. The patient sought unspecified medical attention. At the time of the report, the outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Haematoma
Clinical narrative: Information has been received from a pharmacist concerning a patient who on 31-AUG-2009 was vaccinated IM with a "standard dose" of PNEUMOVAX 23. The patient developed a dime size hematoma after PNEUMOVAX 23 was given. The nurse who administered the vaccine thought that she might had punctured a blood vessel. At the time of reporting, the patient had not recovered. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Musculoskeletal pain, Myalgia, Pyrexia, Rash erythematous
Clinical narrative: Information has been received from a 57 year old female patient who on 08-SEP-2009 was vaccinated with one dose of PNEUMOVAX 23 (lot # 663012/1163X). Concomitant therapy included influenza virus vaccine (unspecified). ON 08-SEP-2009 the patient experienced muscle pain in the shoulder and thumb sized red splotches. The patient did not seek for medical attention. At the time of the report, the patient was not recovered. Follow-up information has been received from the consumer's husband who indicated that suspect therapy on the same day included a dose of influenza virus split virion 3v vaccine inactivated  (MSD) (Lot # 06449111A) on the left shoulder. Subsequently, the patient had severe pain in her left shoulder, fever and blotchiness around the injection site to her elbow. At the time of the report the patient's outcome was not specified. This is one of several reports received from the same source. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash macular
Clinical narrative: Information has been received from a 57 year old female patient who on 08-SEP-2009 was vaccinated with one dose of PNEUMOVAX 23 (lot # 663012/1163X). Concomitant therapy included influenza virus vaccine (unspecified). ON 08-SEP-2009 the patient experienced muscle pain in the shoulder and thumb sized red splotches. The patient did not seek for medical attention. At the time of the report, the patient was not recovered. Follow-up information has been received from the consumer's husband who indicated that suspect therapy on the same day included a dose of influenza virus split virion 3v vaccine inactivated  (MSD) (Lot # 06449111A) on the left shoulder. Subsequently, the patient had severe pain in her left shoulder, fever and blotchiness around the injection site to her elbow. At the time of the report the patient's outcome was not specified. This is one of several reports received from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: Information was received from a pharmacist concerning an approximately 66 year old female with sulfa and penicillin allergy, TB active positive test and an allergy to bee stings who was vaccinated with the first dose of PNEUMOVAX 23 (manufacturer unknown) in 2006.  It was reported that the patient experienced redness, swelling at site after the vaccine. The patient subsequently experienced redness at site administration, hardness under skin and warmness to touch while on therapy with ZOSTAVAX (Merck) (MSD, WAES 0908USA04736). No further information is available.
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Gait disturbance, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a  24 month old male patient with no pertinent medical history or drug allergy who on 12-SEP-2009 in the morning was vaccinated with a dose of PNEUMOVAX 23 (Lot # 662667/1435X), SC in left thigh. On 12-SEP-2009 afternoon after receiving the vaccine, the patient developed local reaction of redness, swelling, and tender to the touch. The area was raised and the patient could not walk on his leg. He had a temperature of 101.4 degrees. The patient's mother was instructed to give him MOTRIN and apply cold compresses tothe area. The patient's mother has sought medical attention through a call. At the time of this report, the patient had not recovered. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 662667/1435X were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information has been received from the physician concerning this patient. The physician reported that the patient on 12-SEP-2009 received a dose of PNEUMOVAX 23 (Lot # 662667/1435X), SC in left thigh. The same day, patient experienced fever of 101.4 degrees after 3-4 hours of vaccination. The patient was to bear weight on leg, seemed to be in severe pain, tender to touch. The patient has sought medical attention. At the time of this report, the patient recovered from the events. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a  24 month old male patient with no pertinent medical history or drug allergy who on 12-SEP-2009 in the morning was vaccinated with a dose of PNEUMOVAX 23 (Lot # 662667/1435X), SC in left thigh. On 12-SEP-2009 afternoon after receiving the vaccine, the patient developed local reaction of redness, swelling, and tender to the touch. The area was raised and the patient could not walk on his leg. He had a temperature of 101.4 degrees. The patient's mother was instructed to give him MOTRIN and apply cold compresses tothe area. The patient's mother has sought medical attention through a call. At the time of this report, the patient had not recovered. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 662667/1435X were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information has been received from the physician concerning this patient. The physician reported that the patient on 12-SEP-2009 received a dose of PNEUMOVAX 23 (Lot # 662667/1435X), SC in left thigh. The same day, patient experienced fever of 101.4 degrees after 3-4 hours of vaccination. The patient was to bear weight on leg, seemed to be in severe pain, tender to touch. The patient has sought medical attention. At the time of this report, the patient recovered from the events. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site rash
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with 0.5 ml dose of PNEUMOVAX 23. Subsequently the patient developed rash from elbow to shoulder on the arm that received the injection. No lot number was provided. The patient had sought unknown medical attention. At the time of report the patient's status was unknown. This is one of several reports from the same source. On 15-SEP-2009 all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Chills, Injection site induration, Pain, Pyrexia
Clinical narrative: Information has been received from a non healthcare professional, who was informed by a nurse from the physician's office, concerning a patient who on 01-SEP-2009 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 662905/1162X) injection, and on 02-SEP-2009 experienced fever, hard knot under the injection site, cellulitis, chills and severe pain. The patient's outcome was not reported. The patient sought unspecified medical attention. Follow-up information was received from a non-health care professional. It was reported that the AE was closed and no further investigation was pending. No additional information about the adverse event was provided. This is one of two reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site rash
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a 0.5 ml dose of PNEUMOVAX 23. Subsequently the patient developed rash from elbow to shoulder on the arm that received the injection. No lot number was provided. The patient had sought unknown medical attention. At the time of report the patient's status was unknown. This is one of several reports from the same source. On 15-SEP-2009 all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Feeling abnormal, Injection site mass
Clinical narrative: Information has been received from a pharmacist concerning a 66 year old female patient with penicillin allergy who on 08-SEP-2009 was vaccinated IM with a 0.5 ml dose of PNEUMOVAX 23(Lot#663888/0627Y). Subsequently the patient said she "felt the vaccine going into her arm". On 09-SEP-2009 the patient woke up in the morning with a lump at the injection site. The patient sought medical attention at the pharmacy. The pharmacist told her to apply ice at the injection site. There were no laboratory studies performed. At the time of the report the patient had not recovered. The pharmacist also reported that the patient had received PNEUMOVAX 23 in the past, but the pharmacist did not know the date. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Fatigue, Myalgia, Nausea, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 39 year old male patient with no known drug allergies or pertinent medical history who on 27-AUG-2009 was vaccinated IM with a 0.5 ml dose of PNEUMOVAX 23 (Lot #661897/1333X). There was no concomitant medication. On 29-AUG-2009 the patient experienced fever, nausea, lightheadedness and aching. It was unknown if the patient required medical treatment but he returned to the clinic 09-SEP-2009 and stated his symptoms were improving. No laboratory tests were performed. Follow up information has been received from a registered nurse concerning a 39 year old male smoker (1 ppd) patient who on 13-AUG-2009 was vaccinated IM on the deltoid with the first dose of PNEUMOVAX 23 (Lot #661897/1333X). There was no illness at the time of vaccination. On 14-Aug-2009 the patient experienced 2 days of fever, myalgia and fatigue. No office visit, testing or additional follow up. On 17-AUG-2009 the patient recovered. This is one of two reports from the same source. No further information is available.
Age: 39.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 39 year old male patient with no known drug allergies or pertinent medical history who on 27-AUG-2009 was vaccinated IM with a 0.5 ml dose of PNEUMOVAX 23 (Lot #661897/1333X). There was no concomitant medication. On 29-AUG-2009 the patient experienced fever, nausea, lightheadedness and aching. It was unknown if the patient required medical treatment but he returned to the clinic 09-SEP-2009 and stated his symptoms were improving. No laboratory tests were performed. Follow up information has been received from a registered nurse concerning a 39 year old male smoker (1 ppd) patient who on 13-AUG-2009 was vaccinated IM on the deltoid with the first dose of PNEUMOVAX 23 (Lot #661897/1333X). There was no illness at the time of vaccination. On 14-Aug-2009 the patient experienced 2 days of fever, myalgia and fatigue. No office visit, testing or additional follow up. On 17-AUG-2009 the patient recovered. This is one of two reports from the same source. No further information is available.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Disorientation, Dizziness, Headache, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: Information has been received from a 65 year old female consumer with no pertinent medical history and no drug reactions or allergies who on 30-JUN-2009 was vaccinated with her first dose of PNEUMOVAX 23 (lot number was not provided. Concomitant therapy included tetanus toxoid (manufacturer unknown). On 01-JUL-2009 the patient experienced dizziness, disorientation, muscle weakness, stiff neck, congestion and left sided headache. The patient did not seek medical attention and self-treated with ADVIL and oscillococcinum. No lab diagnostic studies were performed. The muscle weakness was resolved on 02-JUL-2009 and the patient fully recovered in 3 weeks. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Respiratory tract congestion
Clinical narrative: Information has been received from a 65 year old female consumer with no pertinent medical history and no drug reactions or allergies who on 30-JUN-2009 was vaccinated with her first dose of PNEUMOVAX 23 (lot number was not provided. Concomitant therapy included tetanus toxoid (manufacturer unknown). On 01-JUL-2009 the patient experienced dizziness, disorientation, muscle weakness, stiff neck, congestion and left sided headache. The patient did not seek medical attention and self-treated with ADVIL and oscillococcinum. No lab diagnostic studies were performed. The muscle weakness was resolved on 02-JUL-2009 and the patient fully recovered in 3 weeks. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: PPV, RAB
Symptoms: Body temperature increased, Chills, Feeling abnormal, Headache, Heart rate normal
Clinical narrative: Information has been received from a nurse concerning a male with asthma and no drug reactions/allergies, who on 08-SEP-2009 was vaccinated with the first 0.5 ml dose of PNEUMOVAX 23 (lot # 661897/1333X) by intramuscular route. The patient experienced fever, nausea, chills and a "welt" at the injection site a few hours after receiving the vaccine. Additionally, the patient began vomiting and developed a photosensitivity and a bad headache on 09-SEP-2009, last pm. At the time of the report all the patient's symptoms persisted. The patient was seen by the medical Director of the travel clinic on 10-SEP-2009 and was given an antiemetic for vomiting. The patient was due to return to the clinic on 11-SEP-2009 for follow up. No laboratory tests were performed. This is one of two reports received for the same source. Follow up information was received from a physician via medical records concerning a healthy 27-year-old non-smoker male with asthma, mild environmental allergies, alcohol use (3 alcoholic beverages per week) and no medication allergies and no illicit drug use and a history of hospitalization for suspected appendicitis (no surgery required) who on 08-SEP2009 was vaccinated SC into the left deltoid with first dose of PNEUMOVAX 23 (lot number 661897/1333X) and third dose of rabies vaccine (manufacturer unknown) at the same site (left deltoid). Concomitant therapy included CLARITIN, albuterol, FLONASE. It was reported that the patient did well at that time and was released to return home. That night, on 08-SEP-2009, the patient began developing significant local reaction at the injection site. He reported fevers as well as some sweats, felt overall poorly, and described myalgias and a headache. He attempted to work on 09-SEP-2009, but was forced to return home where he continued with nausea and vomiting and generally feeling poorly. He contacted the office and was promptly seen. The patient was seen at the office on 10-SEP-2009. The vital signs were: Blood pressure 124/79, pulse 98 regular, respirations 16 and unlabored, temperature 100. On 11-SEP-2009, the patient came to the office for a follow up visit. He reported high temperature (101) with drenching sweats last night (on 10-SEP-2009). The patient had relief of nausea and vomiting with PO odansetron. The patient was taking oral liquids and bland foods. It was reported that the injection site reaction, erythema, myalgias and headache had lessened and improved. There was no evidence of cellulitis. Non-Steroid Anti-Inflammatory Drug (NSAID) and acetaminophen were prescribed. It was reported that the patient was planned to continue with symptomatic treatment. The patient's vital signs in this visit were: Blood pressure 121/71, pulse and temperature of 98.4. The patient recovered from the events on an unspecified date. No further information is available.
Age: 27.0
Sex: M
Vaccine: PPV, RAB
Symptoms: Hyperhidrosis, Injection site erythema, Injection site reaction, Injection site urticaria, Myalgia
Clinical narrative: Information has been received from a nurse concerning a male with asthma and no drug reactions/allergies, who on 08-SEP-2009 was vaccinated with the first 0.5 ml dose of PNEUMOVAX 23 (lot # 661897/1333X) by intramuscular route. The patient experienced fever, nausea, chills and a "welt" at the injection site a few hours after receiving the vaccine. Additionally, the patient began vomiting and developed a photosensitivity and a bad headache on 09-SEP-2009, last pm. At the time of the report all the patient's symptoms persisted. The patient was seen by the medical Director of the travel clinic on 10-SEP-2009 and was given an antiemetic for vomiting. The patient was due to return to the clinic on 11-SEP-2009 for follow up. No laboratory tests were performed. This is one of two reports received for the same source. Follow up information was received from a physician via medical records concerning a healthy 27-year-old non-smoker male with asthma, mild environmental allergies, alcohol use (3 alcoholic beverages per week) and no medication allergies and no illicit drug use and a history of hospitalization for suspected appendicitis (no surgery required) who on 08-SEP2009 was vaccinated SC into the left deltoid with first dose of PNEUMOVAX 23 (lot number 661897/1333X) and third dose of rabies vaccine (manufacturer unknown) at the same site (left deltoid). Concomitant therapy included CLARITIN, albuterol, FLONASE. It was reported that the patient did well at that time and was released to return home. That night, on 08-SEP-2009, the patient began developing significant local reaction at the injection site. He reported fevers as well as some sweats, felt overall poorly, and described myalgias and a headache. He attempted to work on 09-SEP-2009, but was forced to return home where he continued with nausea and vomiting and generally feeling poorly. He contacted the office and was promptly seen. The patient was seen at the office on 10-SEP-2009. The vital signs were: Blood pressure 124/79, pulse 98 regular, respirations 16 and unlabored, temperature 100. On 11-SEP-2009, the patient came to the office for a follow up visit. He reported high temperature (101) with drenching sweats last night (on 10-SEP-2009). The patient had relief of nausea and vomiting with PO odansetron. The patient was taking oral liquids and bland foods. It was reported that the injection site reaction, erythema, myalgias and headache had lessened and improved. There was no evidence of cellulitis. Non-Steroid Anti-Inflammatory Drug (NSAID) and acetaminophen were prescribed. It was reported that the patient was planned to continue with symptomatic treatment. The patient's vital signs in this visit were: Blood pressure 121/71, pulse and temperature of 98.4. The patient recovered from the events on an unspecified date. No further information is available.
Age: 27.0
Sex: M
Vaccine: PPV, RAB
Symptoms: Nausea, Photosensitivity reaction, Pyrexia, Vomiting
Clinical narrative: Information has been received from a nurse concerning a male with asthma and no drug reactions/allergies, who on 08-SEP-2009 was vaccinated with the first 0.5 ml dose of PNEUMOVAX 23 (lot # 661897/1333X) by intramuscular route. The patient experienced fever, nausea, chills and a "welt" at the injection site a few hours after receiving the vaccine. Additionally, the patient began vomiting and developed a photosensitivity and a bad headache on 09-SEP-2009, last pm. At the time of the report all the patient's symptoms persisted. The patient was seen by the medical Director of the travel clinic on 10-SEP-2009 and was given an antiemetic for vomiting. The patient was due to return to the clinic on 11-SEP-2009 for follow up. No laboratory tests were performed. This is one of two reports received for the same source. Follow up information was received from a physician via medical records concerning a healthy 27-year-old non-smoker male with asthma, mild environmental allergies, alcohol use (3 alcoholic beverages per week) and no medication allergies and no illicit drug use and a history of hospitalization for suspected appendicitis (no surgery required) who on 08-SEP2009 was vaccinated SC into the left deltoid with first dose of PNEUMOVAX 23 (lot number 661897/1333X) and third dose of rabies vaccine (manufacturer unknown) at the same site (left deltoid). Concomitant therapy included CLARITIN, albuterol, FLONASE. It was reported that the patient did well at that time and was released to return home. That night, on 08-SEP-2009, the patient began developing significant local reaction at the injection site. He reported fevers as well as some sweats, felt overall poorly, and described myalgias and a headache. He attempted to work on 09-SEP-2009, but was forced to return home where he continued with nausea and vomiting and generally feeling poorly. He contacted the office and was promptly seen. The patient was seen at the office on 10-SEP-2009. The vital signs were: Blood pressure 124/79, pulse 98 regular, respirations 16 and unlabored, temperature 100. On 11-SEP-2009, the patient came to the office for a follow up visit. He reported high temperature (101) with drenching sweats last night (on 10-SEP-2009). The patient had relief of nausea and vomiting with PO odansetron. The patient was taking oral liquids and bland foods. It was reported that the injection site reaction, erythema, myalgias and headache had lessened and improved. There was no evidence of cellulitis. Non-Steroid Anti-Inflammatory Drug (NSAID) and acetaminophen were prescribed. It was reported that the patient was planned to continue with symptomatic treatment. The patient's vital signs in this visit were: Blood pressure 121/71, pulse and temperature of 98.4. The patient recovered from the events on an unspecified date. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Chills, Injection site induration, Pain, Pyrexia
Clinical narrative: Information has been received from a non healthcare professional, who was informed by a nurse from the physician's office, concerning a patient who on 02-SEP-2009 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 662905/1162X) injection, and on 03-SEP-2009 experienced fever, hard knot under the injection site, cellulitis, chills and severe pain. The patient's outcome was not reported. The patient sought unspecified medical attention. This is one of two reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Headache, Injection site erythema, Injection site movement impairment
Clinical narrative: Information has been received from a medical assistant concerning a male office administrator who on 02-SEP-2009 was vaccinated with a dose of PNEUMOVAX 23 (lot # 662905/1162X). On the same day 02-SEP-2009 his wife received a dose of PNEUMOVAX 23 (lot # 662905/1162X). On an unspecified date he was having chills and her temperature was 100.6 degrees. The arm which was vaccinated was achy, red, had red streaks and looked it had cellulitis. It hurt to move that arm. The arm was warm to the touch and felt like a softball. He also experienced a headache. The patient's outcome was unknown. His wife had no symptoms. This is one of two reports from the same source. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site streaking, Injection site warmth
Clinical narrative: Information has been received from a medical assistant concerning a male office administrator who on 02-SEP-2009 was vaccinated with a dose of PNEUMOVAX 23 (lot # 662905/1162X). On the same day 02-SEP-2009 his wife received a dose of PNEUMOVAX 23 (lot # 662905/1162X). On an unspecified date he was having chills and her temperature was 100.6 degrees. The arm which was vaccinated was achy, red, had red streaks and looked it had cellulitis. It hurt to move that arm. The arm was warm to the touch and felt like a softball. He also experienced a headache. The patient's outcome was unknown. His wife had no symptoms. This is one of two reports from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a 65 year old female with no pertinent medical history and no drug allergies, who in 2000 was vaccinated with her first dose of PNEUMOVAX 23, and received her second dose on 08-SEP-2009 (lot # 662842/1296X). There was no concomitant medication. A few hours after the second vaccination, the patient developed redness, swelling, warm at injection site, extending from shoulder to elbow. It was unknown which arm was involved. The patient contacted the office by phone on 10-SEP-2009. No treatment was prescribed. There were no labs and diagnostic tests performed. Follow up information has been received from a pharmacy intern reporting the patient was recovering. She was experienced fever and extreme tiredness along with the injection site reaction. The patient was "getting better" but not yet recovered. This is an amended report. The trade name had been changed from PNEUMOVAX to PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a physician concerning a patient who on an unknown date was vaccinated with PNEUMOVAX 23. The physician reported that on an unspecified date after received PNEUMOVAX 23 the patient experienced swollen and redness at the injection site, and also had a fever that evening. It was noted that in the past this patient received PNEUMOVAX 23 and "had a reaction but not as severe as this time". At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Influenza
Clinical narrative: Information has been received from a female nursing technician who was vaccinated with a 0.5ml dose of PNEUMOVAX 23 "about 5 years ago". After the patient received the vaccine, she got flu symptoms that lasted about a week. Subsequently, the patient recovered "about a week after the injection". Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a registered nurse who told another nurse about a patient who on an unspecified date was vaccinated with a 0.5ml dose of PNEUMOVAX 23. After getting the vaccination, the patient's arm was "sore at the injection site". At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site streaking, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 46 year old male patient who on 17-SEP-2009 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (lot number 662667/1435X). Concomitant therapy included influenza virus vaccine (manufacturer unknown), NEXIUM, alendronate sodium (MSD), WELLBUTRIN, allopurinol, levothyroxine Na, carvedilol, enalapril maleate (manufacturer unknown), warfarin, LORTAB, vitamins (unspecified), ibuprofen and colchicine. The patient was also on therapy with CELEXA 20 mg. On 18-SEP-2009, the patient experienced an adverse reaction. The event was a red ball or knot at the injection site, warm to touch with red streaks going down the arm. No medication was given. There was no ER visit, hospitalization or significant disability. The patient did not die or had life threatening events. At the time of the report the patient's outcome was unknown. Follow up information received on 25-SEP-2009 from licensed practical nurse indicated that the patient was a male, with a medical history of gout, arthritis, depression and allergies to PERCOCET and nitroglycerine, who was vaccinated with dose of PNEUMOVAX 23 (lot number 662667/1435X), intramuscularly into the right deltoid. Concomitant vaccination given on 17-SEP-2009 included a dose of FLUZONE (lot # U3195AA), intramuscularly into left deltoid. Concomitant therapy included prednisone. On 13-AUG-2009 the patient started therapy with CELEXA. On 04 November (year unknown) the patient started therapy with alendronate sodium (MSD). On 30 November (year unknown) the patient started therapy with NEXIUM and allopurinol. The patient was also taken warfarin 5 mg until 13-AUG-2009. On 18-SEP-2009 the patient experienced red arm, with a ball size knot, warmth to touch and painful. The patient goals were International Normalized Ration 2.4-2.6 and blood pressure 100/< dizzy. The patient recovered on an unspecified date. No further information is available. This is an amended report. The concomitant medications were added.
Age: 46.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Skin warm
Clinical narrative: Information has been received from a physician concerning a 46 year old male patient who on 17-SEP-2009 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (lot number 662667/1435X). Concomitant therapy included influenza virus vaccine (manufacturer unknown), NEXIUM, alendronate sodium (MSD), WELLBUTRIN, allopurinol, levothyroxine Na, carvedilol, enalapril maleate (manufacturer unknown), warfarin, LORTAB, vitamins (unspecified), ibuprofen and colchicine. The patient was also on therapy with CELEXA 20 mg. On 18-SEP-2009, the patient experienced an adverse reaction. The event was a red ball or knot at the injection site, warm to touch with red streaks going down the arm. No medication was given. There was no ER visit, hospitalization or significant disability. The patient did not die or had life threatening events. At the time of the report the patient's outcome was unknown. Follow up information received on 25-SEP-2009 from licensed practical nurse indicated that the patient was a male, with a medical history of gout, arthritis, depression and allergies to PERCOCET and nitroglycerine, who was vaccinated with dose of PNEUMOVAX 23 (lot number 662667/1435X), intramuscularly into the right deltoid. Concomitant vaccination given on 17-SEP-2009 included a dose of FLUZONE (lot # U3195AA), intramuscularly into left deltoid. Concomitant therapy included prednisone. On 13-AUG-2009 the patient started therapy with CELEXA. On 04 November (year unknown) the patient started therapy with alendronate sodium (MSD). On 30 November (year unknown) the patient started therapy with NEXIUM and allopurinol. The patient was also taken warfarin 5 mg until 13-AUG-2009. On 18-SEP-2009 the patient experienced red arm, with a ball size knot, warmth to touch and painful. The patient goals were International Normalized Ration 2.4-2.6 and blood pressure 100/< dizzy. The patient recovered on an unspecified date. No further information is available. This is an amended report. The concomitant medications were added.
Age: 39.0
Sex: F
Vaccine: DT, FLU3, PPV
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initial and follow-up information has been received from a licensed practical nurse concerning a 39 year old female patient who was a smoker, with osteoarthritis, Intervertebral disc degeneration, depression, Gastrooesophageal reflux disease (GERD), herpes simplex virus (HSV), Chronic obstructive pulmonary disease (COPD) and allergic reactions to E-MYCIN, TORADOL and NSAIDS who on 11-SEP-2009 was vaccinated IM with a 0.5ml dose of PNEUMOVAX 23 (lot# 662667/1435X) in the right deltoid. Concomitant vaccinations administered on the same day included an IM dose of influenza virus vaccine (unspecified) (lot# U3195AA) in the left deltoid and an IM dose of diphtheria toxoid (+) tetanus toxoid (lot# U2590CA) in the right deltoid. Concomitant therapy included trazodone HCl, lithium, atenolol, rizatriptan benzoate, LYRICA, VALTREX, ELMIRON, TEGRETOL, PRISTIQ, cyclobenzaprine HCl, NEXIUM, PROTONIX, SPIRIVA, INVEGA, VOLTAREN, misoprostol, omeprazole (manufacturer unknown), RISPERDAL, PHENERGAN and albuterol. On 15-SEP-2009 the patient developed a red streak at the injection site, localized to deltoid and triceps regions, warm to touch with red streaks going down the arm, arm was swollen and painful. The patient was told to apply ice to her arm and to take TYLENOL. At the time of the report, the patient's status was unknown. Follow-up information has been received from a licensed practical nurse who reported that the patient had headache and nausea at the time of vaccination. At the time of the report, the patient recovered from all the symptoms on an unspecified date. Additional information is not expected.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Palpitations, Pyrexia
Clinical narrative: Information has been received from a 51 year old female with "mast cell problems", allergy to "opiods", AVELOX, BACTRIM and LEVAQUIN, who on 21-SEP-2009 was vaccinated with a dose of PNEUMOVAX 23 vaccine. Concomitant therapy included influenza virus vaccine (unspecified), doxepin HCl and TYLENOL. The consumer reported that she experienced an allergic reaction after receiving a dose of PNEUMOVAX 23 vaccine and flu vaccine. The patient also developed red swelling from elbow to her neck. She also had fever and raced heart beats. The patient has sought unspecified medical attention. At the time of this report, the patient was recovering. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a lab technician concerning a female patient "in her 60s" who on 23-SEP-2009 was vaccinated with a dose of PNEUMOVAX (Lot # 662841/0626Y) 0.5 ml, IM.  On 23-SEP-2009 the patient experienced injection site reaction of soreness, redness and hot to touch.  The patient has sought medical attention at physician's office on 24-SEP-2009 and was advised to apply compress to the area.  Lab technician did not know if the patient had received PNEUMOVAX in the past.  At the time of this report, the patient was not recovered.  This is one of several reports received from the same source.  Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 56 year old female patient who on 15-SEP-2009 was vaccinated with a dose of 0.5 ml of PNEUMOVAX 23 (Lot # 665423/1295Y valid for varicella virus vaccine live (Merck). Concomitant therapy included other medication that the reporter mentioned as unknown. It was reported that the patient developed redness, a hard spot and swelling from the elbow to the shoulder. The patient mentioned that the swelling was so bad that she could not see her elbow. She had been applying ice packs with no relief. The patient had contacted the emergency room nurses but had not actually gone to emergency room. The nurse also stated that prior to the vaccination the patient told her she had received PNEUMOVAX 23 several times, but no medical documentation could be found about it. At the time of reporting the patient's redness, a hard spot and swelling from the elbow to the shoulder persisted. This is one of two reports from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Malaise
Clinical narrative: Information has been received from a registered nurse concerning a 65 year old female patient with no known drug reactions/allergies or pertinent medical history who on 15-SEP-2009 was vaccinated with PNEUMOVAX 23 (Lot # 665423/1295Y a varicella virus vaccine live (Merck) number. The information was provided to the registered nurse by a patient's friend. There was no concomitant medication. The nurse reported that in September 2009, the patient developed swelling in the injection arm and was "really sick". No lab tests were performed to this patient. It was noted that the patient refused to go to the emergency room. At the time of the report the patient had not recovered. Additional information has been requested. This is one of two reports received from the same source.
Age: 80.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: Information has been received from a home health nurse concerning an 80's year old female patient with "some kind of chronic respiratory problem" who was vaccinated with the first 0.5ml dose of PNEUMOVAX 23 approximately 11 months ago. On 24-SEP-2009 the patient was vaccinated with the second 0.5ml dose of PNEUMOVAX 23 (lot# 661577/1161X) IM in the right deltoid. Concomitant therapy included a dose of influenza virus vaccine (unspecified) in left arm and COUMADIN. On 25-SEP-2009 the patient's right arm was swollen, red, warm to touch and tender. Unspecified medical attention was sought. The patient was given TYLENOL and moist pack. There were no laboratory diagnostic studies performed. At the time of the report, the patient had not recovered. No further information is available.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Information has been received from a lab technician concerning a female patient "in her 60s" who on 23-SEP-2009 was vaccinated with a dose of PNEUMOVAX 23 vaccine, (Lot# 662841/0626Y) 0.5 ml, IM. On 23-SEP-2009 the patient experienced injection site reaction of soreness, redness and hot to touch. The patient has sought medical attention at physician's office on 24-SEP-2009 and was advised to apply compress to the area. Lab technician did not know if the patient had received PNEUMOVAX 23 vaccine in the past. At the time of this report, the patient was not recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Injection site haematoma, Underdose
Clinical narrative: Information has been received from a pharmacist concerning a 48 year old female with no pertinent medical history and sulfonamide allergy and drug hypersensitivity to triptophans and codeine who on 21-SEP-2009 was vaccinated intramuscularly with a dose of PNEUMOVAX (LOT # 663152/0024Y).  Concomitant therapy included CITALOPRAM.  On 21-SEP-2009, after vaccination, the patient experienced bruise at the injection site.  The patient also received less than recommended amount because the drug leaked during the vaccine administration.  No lab diagnostic was performed.  The patient sought unspecified medical attention.  No further information was available at this time of the report.  On 19-OCT-2009, follow-up information received from the pharmacist.  It was stated that the dose received on 21-SEP-2009 was the patient's first dose of PNEUMOVAX in "R/L".  After the shot given, the patient developed a large bruise on arm.  It was also stated that it seemed like some vaccine leaked/sprayed out of syringe when shot given.  The patient was completely fine after shot given other than bruise.  He had recovered on an unspecified date.  No further information is available.
Age: 60.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Dizziness, Headache, Injection site erythema, Injection site pain, Pain
Clinical narrative: Information has been received from a clinic staff concerning a 60 year old female with a history of coeliac disease who "6 years ago" in approximately 2003 was vaccinated with the second 0.5mL dose of PNEUMOVAX 23 (LOT#, route not reported). Concomitant vaccination included a dose of influenza virus vaccine (unspecified) (manufacturer unknown). Later in the day (it was also reported as on 17-SEP-2009), the patient developed aches, pain and redness at injection site, dizziness and a headache. The patient also developed a 103 degree fever that may have occurred the next day. The patient sought unspecified medical attention. The patient's outcome was unknown at this time of the report. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a clinic staff concerning a 60 year old female with a history of coeliac disease who "6 years ago" in approximately 2003 was vaccinated with the second 0.5mL dose of PNEUMOVAX 23 (LOT#, route not reported). Concomitant vaccination included a dose of influenza virus vaccine (unspecified) (manufacturer unknown). Later in the day (it was also reported as on 17-SEP-2009), the patient developed aches, pain and redness at injection site, dizziness and a headache. The patient also developed a 103 degree fever that may have occurred the next day. The patient sought unspecified medical attention. The patient's outcome was unknown at this time of the report. Additional information has been requested.
Age: 0.8
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 9 month old female who on 16-SEP-2009 was vaccinated with a dose of PNEUMOVAX 23 vaccine instead of a flu shot due to human error. No adverse effects noted. The patient sought unspecified medical attention. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a pharmacist concerning a 50 year old male with no medical history or drugs allergies, who on 15-SEP-2009 was vaccinated with a 0.5 mL first dose of PNEUMOVAX 23 (lot # 663888/0627Y), intramuscularly. There was no concomitant medication. The patient developed soreness at the injection site of the left upper arm within a few hours of receiving the PNEUMOVAX 23. On 17-SEP-2009, the patient developed a red, tender area about 3 inches in size near the injection site. No laboratories studies performed. The patient sought medical attention through a phone call to his pharmacist. At the time of this report the patient had not recovered. Follow up information received from a pharmacist indicated that on 15-SEP-2009 the patient received the dose of PNEUMOVAX 23 (lot # 663888/0627Y), intramuscularly in the left arm. On the same date the patient was also vaccinated with a dose of FLUVIRIN (lot # 9784IPI) intramuscularly in the left arm. The patient developed soreness at the injection site of his left upper arm, red and tenderness at injection site were also developed by the patient. The patient's outcome is unknown. Follow up information has been received form the pharmacist who reported the patient's outcome as not recovered. No further information is available.