chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injection site inflammation, Pyrexia
Clinical narrative: Information has been received from a healthcare professional concerning a female patient who on 16-Dec-2008 was vaccinated intramuscularly with a 0.5ml dose of PNEUMOVAX 23 (lot# 659921/1679U). On 17-Dec-2008 the patient had a fever 102F and huge inflammation at the injection site. The patient sought unspecified medical attention by spoke with the office. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met requirements and was released. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Initial and follow-up information has been received from a registered pharmacist concerning a 53 year old female patient who on 15-DEC-2008 was vaccinated with a dose of PNEUMOVAX (lot # 661529/0868X) and had previously been vaccinated with a dose of the same vaccine.  Within 24 hours of vaccination, the patient developed swelling and warmth down her injection arm and was seen by the doctor.  PREDNISONE was prescribed for her.  At the time of the report the patient was recovering.  This is one of three reports received from the same source.  Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from an office manager concerning a 52 year old female patient who on 10-DEC-2008 was vaccinated with PNEUMOVAX (lot #661529/0868X) intramuscularly. Subsequently the patient experienced cellulitis at the site of administration.  Patient called the practice.  Subsequently, the patient was placed on therapy with antibiotics and recovered.  The practice would like to know if there have been any other of cellulitis concerned with this lot of PNEUMOVAX.  This is one of several reports received from the same source.  A standard lot check investigation was performed.  All in-process quality checks for the lot number 661529/0868X were satisfactory.  The lot met the requirements of the agency and was released.  Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site infection, Injection site reaction
Clinical narrative: Information has been received from a physician concerning a 52 year old female patient with fibromyalgia who on approximately December 1999, 9 years ago, was vaccinated with a dose of with PNEUMOVAX and developed a serious reaction at the injection site.  The physician reported that her arm became red and she was diagnosed with an infection in her arm 2 hours after receiving the vaccine.  The patient was given unspecified antibiotics to treat.  The patient sought unspecific medical attention.  No further information is available.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning a 43 year old female who on 17-December was vaccinated IM with the second dose of PNEUMOVAX 23 (lot#661528/0867X). Subsequently the patient developed injection site reaction after vaccination with PNEUMOVAX 23 vaccine. The patient developed cellulitis and was treated with unspecified antibiotics. The patient's injection site reaction and cellulitis persisted. It was reported that the patient sought medical attention; seen in office. This is one of several reports received from the same source.
Age: 57.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Fatigue, Injection site erythema, Injection site haematoma, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning a 57 year old female who was vaccinated with the first dose of PNEUMOVAX (LOT# not reported), on 12-DEC-2008, was vaccinated IM with the second dose of PNEUMOVAX (LOT# 661528/0867X).  Concomitant vaccine including diphtheria toxoid + pertussis acellular vaccine (unspecified) + tetanus toxoid (manufacture unknown) at same office visit.  Within 3 days of vaccination of the 2nd dose of PNEUMOVAX, the patient developed an injection site reaction.  The patient developed a small bruise, redness, soreness, warmth and a 6.5X5.5 cm area of erythema.  The patient was also tired.  The patient treated with AUGMENTIN, BENADRYL, IBUPROFEN and warm compresses.  The outcome of adverse event was not reported.  It was reported that the patient sought medical attention:  seen in office.  This is one of several reports received from the same source.  Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 57 year old female who was vaccinated with the first dose of PNEUMOVAX (LOT# not reported), on 12-DEC-2008, was vaccinated IM with the second dose of PNEUMOVAX (LOT# 661528/0867X).  Concomitant vaccine including diphtheria toxoid + pertussis acellular vaccine (unspecified) + tetanus toxoid (manufacture unknown) at same office visit.  Within 3 days of vaccination of the 2nd dose of PNEUMOVAX, the patient developed an injection site reaction.  The patient developed a small bruise, redness, soreness, warmth and a 6.5X5.5 cm area of erythema.  The patient was also tired.  The patient treated with AUGMENTIN, BENADRYL, IBUPROFEN and warm compresses.  The outcome of adverse event was not reported.  It was reported that the patient sought medical attention:  seen in office.  This is one of several reports received from the same source.  Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Urticaria
Clinical narrative: Information has been received from a 74 year old female with a previous reaction to Tetanus shot and allergy to egg whites, yeast who recently was vaccinated with PNEUMOVAX (route and site not reported) and tetanus shots (manufacturers and names unspecified). Subsequently, after receiving the vaccines the patient broke out hives.  The patient thought it was the tetanus shot because she previously had a reaction to one.  The patient also mentioned developing hives after taking progesterone (manufacturer unspecified).  No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Muscular weakness, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a his mother who on 15-DEC-2008 was vaccinated with a dose of PNEUMOVAX (manufacturer unknown). After the injection an immediate sharp severe pain was described and a weekend feeling in the arm which continued until early 18-DEC-2008. The patient was following up with another physician on 19-DEC-2008, but the pain had not gone away. The reporter explained that while the vaccine was administered in the arm it was extremely high and possible into the acromial process area. His concern was the vaccine was possibly injected into the bursal sac or the intra-articular area of the shoulder. The needle size was not clear. The patient went to an orthopedic surgeon on 19-DEC-2008 and the surgeon believed the injection was intra-articular space in supraspinatus, tendon or rotator cuff. The patient did not have severe pain at the rest so the surgeon did not feel she had an infection. The patient was placed on steroids and anti-inflammatory medication. The patient was returning to the surgeon on Monday, 22-DEC-2008 and the surgeon may order an MRI. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Initial and follow-up information has been received from a registered pharmacist concerning a 55 year old male patient who on 15-DEC-2008 was vaccinated with a dose of PNEUMOVAX (lot # 661529/0858X).  Within 24 hours of vaccination, the patient developed swelling and warmth down at the injection site.  The patient sought unspecific medical attention from a physician.  This is one of three reports received from the same source.  Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse concerning a 75 year old female with hypertension, hypercholesterolaemia, osteoporosis and no allergy who on 18-DEC-2008 was vaccinated with the first dose of PNEUMOVAX IM, 0.5ml (lot # 661577/1161X). Concomitant therapy included simvastatin and alendronate sodium. On 18-DEC-2008 the patient experienced redness, pain, swelling and hot sensation on her arm at the injection site after receiving the vaccination. The patient sought medical attention by phone call. A lot check has been requested. A standard lot check investigation was performed. All in-process quality were satisfactory. The lot met the requirements of the Center and was released. This is one of  two reported received from the same source. Additional information has been requested;
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse concerning a 71 year old female with hypercholesterolaemia, coronary artery disease, aortic valve stenosis and PENICILLIN allergy who on 11-DEC-2008 was vaccinated with the first dose of PNEUMOVAX IM, 0.5ml (lot# 661577/1161X).  Concomitant therapy included COUMADIN and EZETIMIBE (MSD).  On 11-DEC-2008 the patient experienced redness, pain, swelling and a hot sensation on her arm at the injection site after receiving the vaccination.  The patient sought medical attention by phone call.  A lot check has been requested.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the agency and was released.  This is one of two reports received from the same source.  Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Full blood count, Injected limb mobility decreased, Local reaction
Clinical narrative: Information has been received from a physician concerning two patients in their 50 who on approximately 09-DEC-2008 ("last week") were vaccinated with a dose of PNEUMOVAX (663012/1163X). The physician reported that the two patients experienced a severe local reaction and a fever of 102 degrees within 24 hours of being vaccinated with PNEUMOVAX. The physician contacted the center and was told to discontinue using lot # 663012/1163X however a specific explanation for this was not available at the time of the call. The two patients sought unspecified medical attention. At the time of the report the two patients were recovered. Attempts are being made to obtain additional identifying information to distinguish the individual patients. Follow up information received from an office manager indicated that one patient was a 50 year old male. The patient received a dose of PNEUMOVAX (lot # 663012/1163X) on 10-DEC-2008. The patient was not hospitalized. Follow-up information from the office manager indicated that the 50 year old patient with no medical history or allergies received a dose of PNEUMOVAX IM, 0.5 mL (lot # 663012/1163X) on 10-DEC-2008. Concomitant therapy included "thyroid mediation" (manufacturer unspecified). Subsequently, the patient couldn't move his arm where he received his injection and experienced chills and fever. The patient saw the physician and a complete blood count was preformed (result unknown). The patient recovered on 15-DEC-2008. This is one of two reported from the same source. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center and was released. This is a consolidation of two reports concerning the same patient. Additional information has been requested. It has been determined that WAES # 0812USA04572 is a duplicate of WAES # 0812USA04696. Therefore, WAES # 0812USA04572 is being deleted from our files and the reports consolidated into 0812USA04696.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning two patients in their 50 who on approximately 09-DEC-2008 ("last week") were vaccinated with a dose of PNEUMOVAX (663012/1163X). The physician reported that the two patients experienced a severe local reaction and a fever of 102 degrees within 24 hours of being vaccinated with PNEUMOVAX. The physician contacted the center and was told to discontinue using lot # 663012/1163X however a specific explanation for this was not available at the time of the call. The two patients sought unspecified medical attention. At the time of the report the two patients were recovered. Attempts are being made to obtain additional identifying information to distinguish the individual patients. Follow up information received from an office manager indicated that one patient was a 50 year old male. The patient received a dose of PNEUMOVAX (lot # 663012/1163X) on 10-DEC-2008. The patient was not hospitalized. Follow-up information from the office manager indicated that the 50 year old patient with no medical history or allergies received a dose of PNEUMOVAX IM, 0.5 mL (lot # 663012/1163X) on 10-DEC-2008. Concomitant therapy included "thyroid mediation" (manufacturer unspecified). Subsequently, the patient couldn't move his arm where he received his injection and experienced chills and fever. The patient saw the physician and a complete blood count was preformed (result unknown). The patient recovered on 15-DEC-2008. This is one of two reported from the same source. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center and was released. This is a consolidation of two reports concerning the same patient. Additional information has been requested. It has been determined that WAES # 0812USA04572 is a duplicate of WAES # 0812USA04696. Therefore, WAES # 0812USA04572 is being deleted from our files and the reports consolidated into 0812USA04696.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a 58 year old white female patient with allergic reaction to KEFLEX and sulfonamide allergy, and lung cancer stage 4 who on 14-OCT-2008 was vaccinated with PNEUMOVAX (lot # 659148/1382U) IM in the left arm.  Concomitant therapy included first dose of FLUZONE (lot # 02751AA) IM in the left arm.  On 15-OCT-2008 the patient experienced swollen left arm and arm redness.  Subsequently, the patient recovered from left arm swollen and arm redness.  Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Initial and follow-up information has been received from a registered pharmacist concerning a 51 year old female patient who on 15-DEC-2008 was vaccinated with a dose of PNEUMOVAX (lot # 661529/0868X).  Within 24 hous of vaccination, the patient developed swelling and warmth down at the injection site.  The patient's reaction was not as severe and was not seen by a doctor.  This is one of three reports received from the same source.  Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a certified medical assistant concerning a male patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX (Lot # 661577/1161X) and had injection site reactions from PNEUMOVAX.  It is unknown if the patient sought medical attention. At the time of reporting, it is unknown if the patient had recovered.  This is one of several cases received from the same source.  Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a certified medical assistant concerning a male patient who on unspecified date was vaccinated with a dose of PNEUMOVAX and had injection site reactions from PNEUMOVAX.  It is unknown if the patient sought medical attention.  At the time of reporting, it is unknown if the patient had recovered.  This is one of several cases received from the same source.  Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: PPV
Symptoms: Lethargy, Pyrexia, Wrong drug administered
Clinical narrative: Information has been received from a healthcare worker concerning a 12 month old patient who on 15-DEC-2008 was vaccinated with a dose of PNEUMOVAX (lot# not provided) 0.5 ml intramuscularly. Subsequently the patient experienced fever of 101 degrees Fahrenheit and became lethargic. Follow up information was received from the healthcare worker reported that the patient with an allergy to environmental allergens and peanuts who on 15-DEC-2008 at 1:30 PM was erroneously vaccinated with a first dose of PNEUMOVAX (lot # 661529/0868X) in her right leg instead of (PREVNAR) at well-child care. It was reported in follow-up that no adverse event was identified. It was also reported that the patient recovered and no follow up was performed. Follow up information was received from the doctor of osteopathy who reported that the patient had no reportable reaction. It was a case of nursing error nothing related to product confusion. Additional information is not expected.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from an office manager concerning a 66 year old male patient who on 12-NOV-2008 was vaccinated with PNEUMOVAX (lot#661529/0868X) intramuscularly.  Subsequently the patient experienced cellulitis at the site of administration.   Patient called the practice.  Subsequently, the patient was placed on antibiotics and recovered.  The practice would like to know if there have been any other reports of cellulitis concerned with this lot of PNEUMOVAX. A standard lot check investigation was performed.  All in-process quality checks for the lot number 0661529/0868X were satisfactory.  The lot met the requirements of the agency and was released.  This is one of several reports received from the same source.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect route of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a patient who on an unspecified date, was vaccinated with PNEUMOVAX, intradermally. The registered nurse reported that the patient inadvertently received the vaccine intradermally instead of "PPD skin test" due to human error. No adverse reaction reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Hypertension, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Information has been received from a 66 year old female, 188 pounds and 66 inches in height, with allergic reaction to ACE inhibitors, who on 05-DEC-2008, was vaccinated with PNEUMOVAX (Lot # 658447/1132U) 0.5ml. Concomitant therapy included gemfibrozil, CLARITIN, NEXIUM, SYNTHROID, TOPROL XL Tablets) and carisoprodol. The consumer reported that she received the vaccine and that night, at the injection site, her arm was swollen and hard with red circle that was about 4 inches. Then as time went on during the night she was feeling very hot and put cold compress on her head. She reported that she felt "like I was hit by a truck" and felt very sick. The consumer reported that next morning on 06-DEC-2008, she went to the urgent care facility because she felt horrible and when she was at the urgent care facility, she had a fever and her blood pressure was high. The patient stated that the physician at the urgent care facility told her to take TYLENOL (manufacturer unspecified) and aspirin (manufacturer unspecified), but she did not take the aspirin because it was not agree with her stomach. The consumer reported that she felt a lot better, but she still had the red circle, it was itchy and tender at the injection site. The consumer provided her physician's information but a pharmacy was where she received the vaccine. Additional information has been requested. In follow-up, practitioner nurse reported patient's age as 65 years (previously reported by the patient as 66) and the pre-existing allergies: azithromycin, amitriptyline and sulfonamide allergy. The practitioner nurse reported that there were no illnesses at time of vaccination. Additionally, she reported the patient status as unknown (previously reported by the patient as recovering). No further information is available.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site swelling, Malaise, Pyrexia
Clinical narrative: Information has been received from a 66 year old female, 188 pounds and 66 inches in height, with allergic reaction to ACE inhibitors, who on 05-DEC-2008, was vaccinated with PNEUMOVAX (Lot # 658447/1132U) 0.5ml. Concomitant therapy included gemfibrozil, CLARITIN, NEXIUM, SYNTHROID, TOPROL XL Tablets) and carisoprodol. The consumer reported that she received the vaccine and that night, at the injection site, her arm was swollen and hard with red circle that was about 4 inches. Then as time went on during the night she was feeling very hot and put cold compress on her head. She reported that she felt "like I was hit by a truck" and felt very sick. The consumer reported that next morning on 06-DEC-2008, she went to the urgent care facility because she felt horrible and when she was at the urgent care facility, she had a fever and her blood pressure was high. The patient stated that the physician at the urgent care facility told her to take TYLENOL (manufacturer unspecified) and aspirin (manufacturer unspecified), but she did not take the aspirin because it was not agree with her stomach. The consumer reported that she felt a lot better, but she still had the red circle, it was itchy and tender at the injection site. The consumer provided her physician's information but a pharmacy was where she received the vaccine. Additional information has been requested. In follow-up, practitioner nurse reported patient's age as 65 years (previously reported by the patient as 66) and the pre-existing allergies: azithromycin, amitriptyline and sulfonamide allergy. The practitioner nurse reported that there were no illnesses at time of vaccination. Additionally, she reported the patient status as unknown (previously reported by the patient as recovering). No further information is available.
Age: 83.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site discomfort, Skin warm, Tenderness
Clinical narrative: Information has been received from a physician concerning an 83 year old female patient with chronic obstructive pulmonary disease and arthritis and a history of breast cancer who on 24-OCT-2008 was vaccinated intramuscularly in the hip with a dose of PNEUMOVAX (lot # 661529/0868X).  Concomitant therapy included influenza virus vaccine (unspecified).  The patient called the office on 01-DEC-2008 complaining of discomfort in the hip near the injection site.  Injection was given in the hip because the patient had a mastectomy with lymph involvement previously.  She was given a flu shot (manufacturer unknown) in her "good arm" at the same visit on 24-OCT-2008 so the decision was made to give the dose of PNEUMOVAX in the hip.  It was unknown when the discomfort started.  Upon examination by the physician in December 2008 the area was minimally tender with no warmth, erythema, or induration.  The patient's husband reported the area was warm.  Physician asked for a lot check on 661529/0868X.  The patient sought unspecific medical attention.  At the time of the report the patient was not recovered.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the agency and was released.  Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Body temperature increased, Full blood count, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning two patients in their 50 who on approximately 09-DEC-2008 ( " last week") were vaccinated with a dose of PNEUMOVAX (lot # 663012/1163X). The physician reported that the two patients experienced a severe local reaction and a fever of 102 degrees within 24 hours of being vaccinated with PNEUMOVAX. The physician contacted the center for disease control and was told to discontinue using lot # 663012/1163X however a specific explanation for this was not available at the time of the call. The two patients sought unspecific medical attention. At the time of the report the two patients were recovered. Attempts are being mad to obtain additional identifying information to distinguish the individual patients. Follow up information received from an office manager indicated that one patient was 67 year old female. The patient received a dose of PNEUMOVAX (lot # 663012/1163X) on 09-DEC-2008. The patient went to urgent care but was not hospitalized. Additional information was received from an office manager concerning a 67-year-old female with a codeine allergy who on 09-DEC-2008 was vaccinated with a 0.5 ml dose of PNEUMOVAX (lot # 663012/1163X) intramuscularly. The patient experienced upper respiratory infection after receiving PNEUMOVAX. The patient developed a 102 degree fever and felt weak. The patient also developed 15 cm of redness and swelling at the injection site. The patient went to an emergency room and was released. Laboratory/diagnostic studies were performed and included a complete blood count. This is one of two reports from the same source. A standard lot check investigation was performed. 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 a consolidation of two reports concerning the same patient. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Local reaction, Pyrexia, Upper respiratory tract infection
Clinical narrative: Information has been received from a physician concerning two patients in their 50 who on approximately 09-DEC-2008 ( " last week") were vaccinated with a dose of PNEUMOVAX (lot # 663012/1163X). The physician reported that the two patients experienced a severe local reaction and a fever of 102 degrees within 24 hours of being vaccinated with PNEUMOVAX. The physician contacted the center for disease control and was told to discontinue using lot # 663012/1163X however a specific explanation for this was not available at the time of the call. The two patients sought unspecific medical attention. At the time of the report the two patients were recovered. Attempts are being mad to obtain additional identifying information to distinguish the individual patients. Follow up information received from an office manager indicated that one patient was 67 year old female. The patient received a dose of PNEUMOVAX (lot # 663012/1163X) on 09-DEC-2008. The patient went to urgent care but was not hospitalized. Additional information was received from an office manager concerning a 67-year-old female with a codeine allergy who on 09-DEC-2008 was vaccinated with a 0.5 ml dose of PNEUMOVAX (lot # 663012/1163X) intramuscularly. The patient experienced upper respiratory infection after receiving PNEUMOVAX. The patient developed a 102 degree fever and felt weak. The patient also developed 15 cm of redness and swelling at the injection site. The patient went to an emergency room and was released. Laboratory/diagnostic studies were performed and included a complete blood count. This is one of two reports from the same source. A standard lot check investigation was performed. 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 a consolidation of two reports concerning the same patient. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Pain in extremity, Skin warm
Clinical narrative: Information has been received from a 71 year old female healthcare worker with hypertension, hypothyroidism, tinnitus, latex allergy, iodine allergy and food allergy who on 19-NOV-2008 was vaccinated intramuscularly into the right arm with the first dose of PNEUMOVAX. Concomitant therapy included SYNTHROID, verapamil, KLOR-CON, EVISTA, fexofenadine hydrochloride, vitamins (unspecified), fluticasone propionate and ASTELIN and "SYNVISTA". On 19-NOV-2008 the patient reported her arm was sore and "really hurt". On 20-DEC-2008 her right arm was red and warm to touch. her right arm was swollen from the injection site to across her arm in both sides almost to the underside. Her symptoms resolved after 2.5 to 3 weeks. The patient sought medical attention by the telephone. At the time of the report the patient was recovered. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Injection site inflammation, Pyrexia
Clinical narrative: Information has been received from a healthcare worker concerning a male patient who on 11-DEC-2008 was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX (lot #659921/1679U). The healthcare worker reported that the patient had a fever of 104F and huge inflammation at the injection site. The patient called the medical line on 13-DEC-2008 or 14-DEC-2009 and was treated with BIAXIN. A lot search was requested. The patient sought unspecified medical attention. It was also reported that the patient was vaccinated with a dose of PNEUMOVAX at least 5 years ago. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center and was released. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Vomiting, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 12 month old female with a history of bronchiolitis at 3 month of age, reactive airway issues when sick and was exposure to the stomach virus on 29-DEC-2008 who on 30-DEC-2008 was vaccinated with PNEUMOVAX (lot # 660718/0551X) by accident, IM, 0.5ml. The office was out of PREVENAR and the nurse who administered the PNEUMOVAX vaccine thought it was the same as PREVENAR because she saw the word pneumococcal. On 31-DEC-2008 the patient vomited once and had watery stools that day. The patient went to the emergency room on 31-DEC-2008 and was treated with PHENEGRAN. On 01-JAN-2009 the patient vomited and had 3 or 4 watery stools. At 3:00 am on 02-JAN-2009 the patient threw up once. The patient also had 2 watery stools on 02-JAN-2009. The patient did not perform any lab diagnostics studies. At time of the report, the patient was recovering. Follow-up information has been received from a physician concerning a 12 month old female who on 30-DEC-2008 at 1:26PM was vaccinated with the first dose of PNEUMOVAX vaccine (lot # 660718/0551X) by accident, IM in left leg, 0.5ml. On 31-DEC-2008 the patient developed vomiting and diarrhea that was more likely related to exposure to another child at daycare. Child did go to ER and received antiemetic and did well subsequently. No further information is available.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Skin warm, Tenderness
Clinical narrative: Information has been received from a nurse and a 55 year old male physician who on 02-JAN-2009 was vaccinated with a dose of PNEUMOVAX (Lot# 1163X), IM in right deltoid.  There was no concomitant medication.  On 03-JAN-2009 the patient experienced soreness in his right arm, warmth and pain. The reaction went from 1 inch from the elbow to up to the shoulder and to the back.  It was really tender all around the arm.  There was no change.  The patient never received PNEUMOVAX in the past.  At the time of the reporting, the patient had not recovered.  This is one of several reports received from the same sources.  Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician and a licensed practical nurse concerning a 62 year old female patient with ibuprofen and penicillin allergy and a history of meningitis viral in 1982 who on 30-DEC-2008 was vaccinated IM into the left deltoid with a 0.5ml dose of PNEUMOVAX (lot # 663012/1163X). Concomitant therapy included "10-12 medications". The patient received PNEUMOVAX in the past with no reactions. On 30-DEC-2008 the patient experienced itching, pain and slight rash at the injection site (left deltoid). The patient sought medical attention by phone. At the time of reporting the patient was recovering. This is one of three reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Neck mass, Pain
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of PNEUMOVAX. Subsequently, the patient developed "chills and fatigue" and her clavicle hurt. "A few days later" she developed a "lump" on her neck which looked like it was in a lymph node. The patient sought unspecified medical attention. The physician did not give details on the patient's status or if she had improved or not other than to say "she was fine". Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: Injection site rash, Injection site swelling, Wrong drug administered
Clinical narrative: Information has been received from a physician's assistant (P.A) concerning a 24 months old male patient with no known drug reactions/allergies and medical history who on 09-JAN-2009 was inadvertently vaccinated intramuscularly on the thigh with a 0.5ml dose of PNEUMOVAX instead PREVENAR. Concomitant therapy included HAVRIX. The physician's assistant reported that on 09-JAN-2009 the patient experienced swelling and rash on the injection site area. The patient sought medical attention saw the P.A. At the time of reporting the patient was not recovered. This is one of two reports received from siblings. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a patient who was vaccinated with PNEUMOVAX (lot # not provided). Subsequently the patient experienced injection site reactions. The patient had redness, swelling, pain and cellulitis at the injection site. The patient had sought medical attention. At the time of reporting the patient had recovered from injection site reactions. Follow-up information was received on 14-Jan-2009 from the nurse. The patient had the PNEUMOVAX vaccine administration in approximately 2008, "about a year ago." The patient had random lot number (lot number not provided). The patient developed severe cellulitis reactions immediately after or by the evening of the PNEUMOVAX vaccine administration. The patient was treated for cellulitis and was put either on an (unspecified) antibiotic and/or (unspecified) steroid. Follow-up information was received from an office manager who confirmed that several patients had injection site reactions. Follow-up information has been received from the licensed practical nurse (LPN). It was reported that on 14-NOV-2008, at 9:00 am, a 60 year old white male was vaccinated SQ with the second dose of PNEUMOVAX (lot # 1295X). Subsequently, the patient developed cellulitis in given arm, edema shoulder to elbow, hot to touch, redness, fever. The patient was treated with the symptoms lasting 7-10 days. At the time of this report, the patient was recovered. This is one of several reports from the same source. The nurse requested a lot check. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Oedema, Pyrexia, Skin warm
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a patient who was vaccinated with PNEUMOVAX (lot # not provided). Subsequently the patient experienced injection site reactions. The patient had redness, swelling, pain and cellulitis at the injection site. The patient had sought medical attention. At the time of reporting the patient had recovered from injection site reactions. Follow-up information was received on 14-Jan-2009 from the nurse. The patient had the PNEUMOVAX vaccine administration in approximately 2008, "about a year ago." The patient had random lot number (lot number not provided). The patient developed severe cellulitis reactions immediately after or by the evening of the PNEUMOVAX vaccine administration. The patient was treated for cellulitis and was put either on an (unspecified) antibiotic and/or (unspecified) steroid. Follow-up information was received from an office manager who confirmed that several patients had injection site reactions. Follow-up information has been received from the licensed practical nurse (LPN). It was reported that on 14-NOV-2008, at 9:00 am, a 60 year old white male was vaccinated SQ with the second dose of PNEUMOVAX (lot # 1295X). Subsequently, the patient developed cellulitis in given arm, edema shoulder to elbow, hot to touch, redness, fever. The patient was treated with the symptoms lasting 7-10 days. At the time of this report, the patient was recovered. This is one of several reports from the same source. The nurse requested a lot check. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Injection site rash, Injection site swelling, Wrong drug administered
Clinical narrative: Information has been received from a physician assistant (P.A.) concerning a 24 months old female patient with no known drug reactions/allergies and medical history who on 09-JAN-2009 was inadvertently vaccinated intramuscularly on the thigh with a 0.5ml dose of PNEUMOVAX instead of PREVNAR.  Concomitant therapy included HAVRIX.  The physician's assistant reported that on 09-JAN-2009 the patient experienced swelling and rash on the injection site area.  The patient sought medical attention saw the P.A.  At the time of reporting the patient was not recovered.  This is one of two reports received from siblings.  Additional information has been requested.
Age: 41.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Immediate post-injection reaction, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a patient who in November 2008, was vaccinated with PNEUMOVAX. The patient had random lot number (lot number not provided). The patient developed severe cellulitis reactions immediately after or by the evening of the PNEUMOVAX administration. The patient had symptoms, which included swelling, redness, pain and heat at the injection site. The patient was treated for cellulitis and was put either on an (unspecified) antibiotic and/or (unspecified) steroid. The outcome of the patient's adverse reaction was not reported. Follow-up information was received from an office manager who confirmed that several patients had injection site reactions. Follow-up information was received from the licensed practical nurse (LPN). It was reported that on 23-DEC-2008, at 14:00, a 41 year old male was vaccinated SQ with the first dose of PNEUMOVAX (lot #: 662663/0980X). Subsequently, the patient developed redness, fever, edema and was diagnosed with cellulitis at a clinic. The patient was treated with antibiotics with symptoms lasting for 7-10 days. At the time of this report, the patient was recovered. This is one of several reports received from the same source. The nurse requested a lot check. Additional information has been requested.
Age: 41.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Oedema, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a patient who in November 2008, was vaccinated with PNEUMOVAX. The patient had random lot number (lot number not provided). The patient developed severe cellulitis reactions immediately after or by the evening of the PNEUMOVAX administration. The patient had symptoms, which included swelling, redness, pain and heat at the injection site. The patient was treated for cellulitis and was put either on an (unspecified) antibiotic and/or (unspecified) steroid. The outcome of the patient's adverse reaction was not reported. Follow-up information was received from an office manager who confirmed that several patients had injection site reactions. Follow-up information was received from the licensed practical nurse (LPN). It was reported that on 23-DEC-2008, at 14:00, a 41 year old male was vaccinated SQ with the first dose of PNEUMOVAX (lot #: 662663/0980X). Subsequently, the patient developed redness, fever, edema and was diagnosed with cellulitis at a clinic. The patient was treated with antibiotics with symptoms lasting for 7-10 days. At the time of this report, the patient was recovered. This is one of several reports received from the same source. The nurse requested a lot check. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Asthenia, Immediate post-injection reaction, Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who on 12-JAN-2009 was vaccinated with PNEUMOVAX (lot number 662663/0980X). The patient developed severe cellulitis reactions immediately after or by the evening of the PNEUMOVAX administration. The patient had symptoms, which included swelling, redness and heat at the injection site. The patient also experienced pain and weakness. The patient sought medical attention at a express clinic or the emergency room. The patient was prescribed TYLENOL for the pain. The patient was treated for cellulitis and was put either on an (unspecified) antibiotic and/or (unspecified) steroid. The outcome of the patient's adverse reaction was not reported. The nurse requested a lot check. Follow-up information was received from an office manager who confirmed that several patients had injection site reactions. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the Agency 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 swelling, Injection site warmth
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who on 12-JAN-2009 was vaccinated with PNEUMOVAX (lot number 662663/0980X). The patient developed severe cellulitis reactions immediately after or by the evening of the PNEUMOVAX administration. The patient had symptoms, which included swelling, redness and heat at the injection site. The patient also experienced pain and weakness. The patient sought medical attention at a express clinic or the emergency room. The patient was prescribed TYLENOL for the pain. The patient was treated for cellulitis and was put either on an (unspecified) antibiotic and/or (unspecified) steroid. The outcome of the patient's adverse reaction was not reported. The nurse requested a lot check. Follow-up information was received from an office manager who confirmed that several patients had injection site reactions. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the Agency and was released. This is one of several reports received from the same source. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who on 23-DEC-2008 was vaccinated with PNEUMOVAX (lot number 662663/0980X). The patient developed severe cellulitis reactions immediately after or by the evening of the PNEUMOVAX administration. The patient had symptoms, which included swelling, redness, pain and heat at the injection site. The patient went to the express Clinic for a sore arm. The patient was treated for cellulitis and was put either on an (unspecified) antibiotic and/or (unspecified) steroid. The outcome of the patient's adverse reaction was not reported. This is one of several reports received from the same source. Additional information has been received from the office manager who confirmed that several patient had injection site reactions. Additional information has been received from a licensed practical nurse concerning a 79 year old female patient who on 08-JAN-2009 10 AM was vaccinated IM with the first dose of PNEUMOVAX (Lot number 662663/0980X). Subsequently, the patient developed fever, body aches, edema, redness, heat from shoulders to below elbow. Subsequently, the patient was recovered from the adverse events. The patient went to ER to sought medical attention. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Agency and was released. No further information is available.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Oedema, Pain, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who on 23-DEC-2008 was vaccinated with PNEUMOVAX (lot number 662663/0980X). The patient developed severe cellulitis reactions immediately after or by the evening of the PNEUMOVAX administration. The patient had symptoms, which included swelling, redness, pain and heat at the injection site. The patient went to the express Clinic for a sore arm. The patient was treated for cellulitis and was put either on an (unspecified) antibiotic and/or (unspecified) steroid. The outcome of the patient's adverse reaction was not reported. This is one of several reports received from the same source. Additional information has been received from the office manager who confirmed that several patient had injection site reactions. Additional information has been received from a licensed practical nurse concerning a 79 year old female patient who on 08-JAN-2009 10 AM was vaccinated IM with the first dose of PNEUMOVAX (Lot number 662663/0980X). Subsequently, the patient developed fever, body aches, edema, redness, heat from shoulders to below elbow. Subsequently, the patient was recovered from the adverse events. The patient went to ER to sought medical attention. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Agency and was released. No further information is available.