chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Respiratory tract congestion
Clinical narrative: Information has been received from a certified medical assistant concerning 12 patients who on an unknown date were vaccinated with a dose of PNEUMOVAX 23 (Lot number: 663888/0627Y or 662599/1076X).  The certified medical assistant reported that the 12 patients had "reactions to PNEUMOVAX 23 ranging from fevers to 102F to 103F and cellulitis."  Some patients had "cold like symptoms including muscle aches, fever, cough and congestion, starting the day after the PNEUMOVAX 23 was given".  At the time of the report the patient's outcome were not reported.  The certified medical assistant stated that 4 patients went to the emergency room and were placed on IV antibiotics but were not admitted to the hospital.  The other patients sought medical attention at the physician's office.  Follow up information was received from the medical assistant who stated that would like to return PNEUMOVAX 23 that caused patient reactions in the office.  Nurse stated "she understands that routine reports had been noted with PNEUMOVAX 23 in the past but had never reactions such as this in their office".  Follow up information has been received from a nurse who reported that a patient who on unknown date was vaccinated with a dose of PNEUMOVAX 23 (Lot number not specified).  On an unspecified date, the patient had adverse reactions to PNEUMOVAX 23.  This is one of several reports received from the same source.
Age: 58.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Headache, Injected limb mobility decreased, Injection site pain, Myalgia, Tinnitus
Clinical narrative: Information has been received from a 58 year old male consumer with type 2 diabetes mellitus who on 04-NOV-2009 was vaccinated with a dose of PNEUMOVAX 23 (lot# 664654/0823Y) on his left arm at the place of his employment since it was covered by their company. Concomitant vaccination administered on the same day included a dose of influenza virus vaccine (unspecified) (Manufactured by Sanofi Pasteur) on his right arm. Other concomitant therapy included metformin. "4 hours" after receiving the vaccine, the patient developed pain on his left arm specifically "above the injection site" where he received the PNEUMOVAX 23. It was noted that his right arm was fine. It was reported that on 05-NOV-2009, the patient could not move his left arm and he had the pain for "16 hours" at the time of the report. The patient reported that he had been having muscle pain, ringing in his ear and headache but he didn't have fever. The patient called the nurse for medical attention. There were no laboratory diagnostic studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Malaise
Clinical narrative: Information has been received from a pharmacy student concerning a female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23. Subsequently, on an unspecified date the patient experienced an allergic reaction and got sick. It was not an anaphylactic reaction. It was unknown if the patient sought medical attention. At the time of the report, the patient had recovered. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site urticaria
Clinical narrative: Information has been received from a 45 year old female consumer with "multiple chemical sensitivity", secondary adrenal insufficiency, hypoglycaemia, asthma, reactive airways disease. The patient can't take NSIADs and was allergic to Tetanus toxoid which caused muscle spasms and local anesthetics caused her throat to swell. On 01-SEP-2009 the patient was vaccinated with a 0.5 mL dose of PNEUMOVAX 23. Concomitant therapy included hydrocortisone, FLOVENT, SINGULAIR, ZYRTEC, ASTELIN, PROTONIX, MAXAIR and josamycin propionate. It was reported that about 4 hours after getting the injection, the patient developed a wheal at the injection site. The next day, it "grew to 7X 3.5". It was painful and the patient couldn't sleep on it for the four days. It was also reported that the patient in 2001 had gotten a dose of "pneumonia shot" (name and manufacturer of the vaccine unknown). There was no AE to the "pneumonia shot". The patient also stated that she didn't know if the AE she called to report from the first "pneumonia shot" or not. The patient sought unspecified medical attention. Within 2 weeks or getting the pneumococcal vaccine, the patient had recovered. No further information is available.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a 63 year old female patient with sulfonamide allergy and penicillin allergy who on 05-NOV-2009 was vaccinated with a dose of PNEUMOVAX 23 (lot# 664654/0823Y). On 06-NOV-2009 the patient experienced "redness and swelling" from the bicep area to the elbow after vaccination. The patient spoke to the nurse practitioner and was treated with KEFLEX. There was no fever reported. At the time of the report, the patient was improving. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 74 year old female patient with diabetes and no allergies who on 04-NOV-2009 was vaccinated with a 0.5 ml second dose of PNEUMOVAX 23 (Lot number 665300/1314Y) IM in right arm. The patient received the first dose of PNEUMOVAX 23 in the past (unknown date). Concomitant therapy included "a lot of medications". On 05-NOV-2009 the patient's right arm was red and swollen. The size of the area was 7X10 inches of redness and swelling. At the time of the report the patient was recovering. The patient sought medical attention by an office visit on 06-NOV-2009. The patient did not have any lab diagnostics studies performed. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Lymphadenopathy
Clinical narrative: Information has been received from a female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23. Subsequently the patient had an allergic reaction to a pneumonia shot and her lymph nodes filled up. It was unknown if the patient sought any medical attention. At the time of the report, the patient's outcome was unknown. The reporter disconnected the phone before verifying it the shot was PNEUMOVAX 23 or not. No further information is available.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Blister, Cough, Erythema, Injection site erythema, Injection site vesicles
Clinical narrative: Information has been received from a medical assistant concerning a 41 year old female patient with multiple sclerosis and no known drug allergies who on 09-OCT-2009 was vaccinated with a first dose of PNEUMOVAX 23. Concomitant therapy included FIORICET. It was reported that on 09-OCT-2009 the patient developed an erythematous area at the site of injection after administration of PNEUMOVAX 23. On the same day the area now extended down her arm and had blisters (almost zoster-like rash). She also had a cough. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered. This is one of two reports received from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from registered nurse concerning a 65 year old female patient with allergies to penicillin, CIPRO, and THEO-DUR who was vaccinated with the first (lot # not reported) and second dose (Lot # 662270/1135Y) of PNEUMOVAX 23 on 11-MAR-1998 and 09-NOV-2009 respectively. Concomitant therapy included montelukast sodium (MSD), PROTONIX and SEREVENT. On 09-NOV-2009 the patient received the second dose in the right deltoid, IM at 11:00 AM and the same day at 17:00 pm her right arm started to hurt. It was red, swollen and hot. The patient put ice on the area on 09-NOV-2009. The area affected covers 90% of the upper arm. The patient has sought medical attention at office visit. Lab diagnostics studies were not performed. At the time of this report, the patient had not recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema
Clinical narrative: Information has been received from a medical assistant concerning a 34 year old female patient with no known drug allergies or pertinent medical history who on 07-OCT-2009 was vaccinated with a first dose of PNEUMOVAX 23 (lot # 665402/1339Y), 0.5 ml. There was no concomitant medication. ON 08-OCT-2009 the patient developed an erythematous area at the site of injection after administration of PNEUMOVAX 23. The area now extends down her arm. The physician did not think it was cellulitis. Lab diagnostics studies were not performed. The patient sought medical attention at office visit. 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: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Injection site warmth, Rash maculo-papular, Skin warm
Clinical narrative: Information has been received from a nurse concerning a 61 year old female patient with hypothyroidism, sulfonamide allergy, allergic reaction to AUGMENTIN and drug hypersensitivity to DEMEROL, ALLEGRA, COMBIPATCH, ASACOL and LEVAQUIN who on 02-NOV-2009 was vaccinated intramuscularly with the first 0.5 ml dose of PNEUMOVAX 23 (Lot # 662270/1135Y) in her left arm. Concomitant therapy included SYNTHROID, LIPITOR and alendronate sodium (MSD). It was reported that on 02-NOV-2009 evening, the patient had 2 red raised spots and it was hot on the left arm. The patient tried to ice it and took BENADRYL but she had no relief. The nurse mentioned that at the office visit, it was noticed that 90% of the upper arm was affected. The patient was told to use ice, topical BENADRYL. At the time of the report the patient was recovering. No diagnosis tests were performed. This is one of several reports received from the same source. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Fall, Immediate post-injection reaction, Injected limb mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: Information has been received from a 70 year old female consumer with unspecified concomitant medications and no pertinent medical history or drug reactions or allergies reported, who "last week", on approximately 01-NOV-2009 was vaccinated with a dose of PNEUMOVAX 23 (route and lot # unknown) and experienced severe arm pain after receiving the vaccine. No specified lab diagnostics studies performed. It was unknown if the patient sought medical attention. The AE improved on therapy. The consumer stated that on 10-NOV-2009 she recovered. Follow up information has been received from the patient who stated that she received the PNEUMOVAX 23 on 05-NOV-2009 and no other shots were given at the time. The patient did have the seasonal flu shot two to three weeks prior to receiving PNEUMOVAX 23, on approximately 11-OCT-2009. The patient went back to the Doctor's office on 09-NOV-2009 and the Nurse there thought that they actually hit a nerve when they previously gave the patient the PNEUMOVAX 23. Immediately when the patient received the PNEUMOVAX 23 the patient experienced immediate tingling and pain from her shoulder to her wrist and the pain escalated as the day wore on and by bedtime the patient could hardly move her arm. The patient got up during the night she received PNEUMOVAX 23 and the pain was so horrific that she fell to the floor. The patient took ibuprofen and EXCEDRIN for the pain from the shot and later at bedtime a VICODIN for the pain. The patient stated that by the evening of the next day, on 06-NOV-2009, after receiving PNEUMOVAX 23 the pain was less severe but still extreme whenever the patient moved her arm. The patient said that the pain improved every day. As of the day before, on 12-NOV-2009 the patient still had some pain only when she used her arm in certain ways i.e. pulling up her pants was still painful. It was unknown if the patient sought medical attention. It was also reported that the patient recovered on 10-NOV-2009. Follow up information has been received from the physician concerning the 70 year old female patient with anxiety, osteoporosis, high cholesterol and no illness at the time of vaccination. On 15-OCT-2009 at 9:30 am the patient had been vaccinated with a IM dose of AFLURIA (Lot # 018492). On 05-NOV-2009 at 1:00 pm the patient was vaccinated with an IM dose of PNEUMOVAX 23 (Lot # 662842/1296X). It was reported that on 05-NOV-2009 the patient claimed tingling at her right arm after vaccine administration, which resolved completely within 5 days. On 11-NOV-2009 the patient recovered. No laboratory or diagnostic studies were performed. Additional information is expected.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Information has been received from a 70 year old female consumer with unspecified concomitant medications and no pertinent medical history or drug reactions or allergies reported, who "last week", on approximately 01-NOV-2009 was vaccinated with a dose of PNEUMOVAX 23 (route and lot # unknown) and experienced severe arm pain after receiving the vaccine. No specified lab diagnostics studies performed. It was unknown if the patient sought medical attention. The AE improved on therapy. The consumer stated that on 10-NOV-2009 she recovered. Follow up information has been received from the patient who stated that she received the PNEUMOVAX 23 on 05-NOV-2009 and no other shots were given at the time. The patient did have the seasonal flu shot two to three weeks prior to receiving PNEUMOVAX 23, on approximately 11-OCT-2009. The patient went back to the Doctor's office on 09-NOV-2009 and the Nurse there thought that they actually hit a nerve when they previously gave the patient the PNEUMOVAX 23. Immediately when the patient received the PNEUMOVAX 23 the patient experienced immediate tingling and pain from her shoulder to her wrist and the pain escalated as the day wore on and by bedtime the patient could hardly move her arm. The patient got up during the night she received PNEUMOVAX 23 and the pain was so horrific that she fell to the floor. The patient took ibuprofen and EXCEDRIN for the pain from the shot and later at bedtime a VICODIN for the pain. The patient stated that by the evening of the next day, on 06-NOV-2009, after receiving PNEUMOVAX 23 the pain was less severe but still extreme whenever the patient moved her arm. The patient said that the pain improved every day. As of the day before, on 12-NOV-2009 the patient still had some pain only when she used her arm in certain ways i.e. pulling up her pants was still painful. It was unknown if the patient sought medical attention. It was also reported that the patient recovered on 10-NOV-2009. Follow up information has been received from the physician concerning the 70 year old female patient with anxiety, osteoporosis, high cholesterol and no illness at the time of vaccination. On 15-OCT-2009 at 9:30 am the patient had been vaccinated with a IM dose of AFLURIA (Lot # 018492). On 05-NOV-2009 at 1:00 pm the patient was vaccinated with an IM dose of PNEUMOVAX 23 (Lot # 662842/1296X). It was reported that on 05-NOV-2009 the patient claimed tingling at her right arm after vaccine administration, which resolved completely within 5 days. On 11-NOV-2009 the patient recovered. No laboratory or diagnostic studies were performed. Additional information is expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a female consumer who in November 1999 "10 years ago", was vaccinated with the first dose of PNEUMOVAX 23. On 07-NOV-2009 the patient received her second dose of PNEUMOVAX 23. The patient reported that she developed redness at the injection site of the left upper arm the day after receiving her second dose. The redness resolved on 10-NOV-2009 without requiring medical treatment. No laboratory diagnostics studies were preformed. The patient did not seek medical attention. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Induration, Skin warm
Clinical narrative: Information has been received from a director of nursing at the facility concerning a male with spinal cord injury and quadriplegia who in the past (on unspecified date) was vaccinated with a dose of PNEUMOVAX 23. It was reported that on 02-NOV-2009, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose not reported, lot number: 663935/0528Y, expiration date 26-NOV-2009). The nurse stated, the patient developed 7 cm induration that was warm and hard to touch (approximately on 02-NOV-2009). The patient had a temperature of 102 degrees F for 3 days. The patient was seen by the physician and given antibiotic. No laboratory tests were performed. The symptoms resolved on 09-NOV-2009. The patient sought medical attention by visit the physician. This is one of several reports received from the same source. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local reaction, Pain, Skin warm, Swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who during the second week of November 2009, was vaccinated with a dose of PNEUMOVAX 23. Concomitant vaccination administered on the same day included a dose of influenza virus vaccine (unspecified) at a different site. The patient was scheduled to be seen in the office on 11-NOV-2009 for a severe local reaction. At the time of the report, the patient's outcome was unknown.  Follow-up information has been received from a licensed practical nurse who reported that the lot number of PNEUMOVAX 23 is 663214/0037Y. At the time of the report, the patient's outcome was unknown. Follow-up information has been received from a license practical nurse concerning a 50 year old patient with hypertension, type II diabetes and hyperlipidemia and with no known allergies who on 06-NOV-2009 at 11:56 was vaccinated with the first dose of PNEUMOVAX 23 (lot# 6631214/0037Y) IM in the left deltoid. On 07-NOV-2009 at 12:00, the patient experienced swelling pain and warmth. The patient was seen by a physician on 10-NOV-2009. Her symptoms had improved but still had some mild erythema, slight warmth and mild tenderness. This is one of several reports from the same source. Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who during the second week of November 2009, was vaccinated with a dose of PNEUMOVAX 23. Concomitant vaccination administered on the same day included a dose of influenza virus vaccine (unspecified) at a different site. The patient was scheduled to be seen in the office on 11-NOV-2009 for a severe local reaction. At the time of the report, the patient's outcome was unknown.  Follow-up information has been received from a licensed practical nurse who reported that the lot number of PNEUMOVAX 23 is 663214/0037Y. At the time of the report, the patient's outcome was unknown. Follow-up information has been received from a license practical nurse concerning a 50 year old patient with hypertension, type II diabetes and hyperlipidemia and with no known allergies who on 06-NOV-2009 at 11:56 was vaccinated with the first dose of PNEUMOVAX 23 (lot# 6631214/0037Y) IM in the left deltoid. On 07-NOV-2009 at 12:00, the patient experienced swelling pain and warmth. The patient was seen by a physician on 10-NOV-2009. Her symptoms had improved but still had some mild erythema, slight warmth and mild tenderness. This is one of several reports from the same source. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a director of nursing at the facility, concerning a female with respiratory problems who was vaccinated 6 months ago (approximately in May 2009) with a first dose of PNEUMOVAX 23 (route and lot not reported).  It was reported that on 10-NOV-2009, the patient was vaccinated SQ with a second dose of PNEUMOVAX 23 vaccine (lot number: 663935/0528Y, expiration date 26-NOV-2009).  The nurse reported that the patient developed 8 cm and red, hot area at the injection site with in an hour after receiving the vaccine.  No fever noted.  No laboratory tests were performed.  The patient sought medical attention by visit the physician.  At the time of the report the outcome of the patient was unknown.  This is one of several reports received from the same source.  Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain in extremity, Pyrexia, Swelling
Clinical narrative: Information has been received from a registered nurse concerning a 42 year old female patient who on 11-NOV-2009 was vaccinated in the same arm with PNEUMOVAX 23 and the flu vaccine (manufacturer unknown). The registered nurse reported that the next day, on 12-NOV-2009, the patient called her and stated that she had swelling, pain in the arm and a fever. It was unspecified if lab studies were performed. At the time of the report the patient was recovering. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Dyspnoea, Headache
Clinical narrative: Information has been received from a 66 year old female with no pertinent medical history and no drug allergies who couple years ago, in approximately 2007 was vaccinated with a dose of PNEUMOVAX 23 (name and manufacturer unspecified by reporter). Concomitant therapy included ELAVIL and PREMARIN. Right after getting the vaccine, the patient had a reaction that lasted about a day. She remembered feeling dizzy and having a headache and difficulty breathing. At the reporting time the patient had recovered. Additional information is not expected.
Age: 27.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a medical assistant concerning a 27 year old patient who on 02-NOV-2009 was vaccinated intramuscularly with a 0.5 mL dose of PNEUMOVAX 23. Subsequently, the patient experienced redness, warmth and swelling at the injection site. The patient visited the office for medical attention. No laboratory diagnostics studies were performed. 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: 58.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Decreased appetite, Nausea, No reaction on previous exposure to drug, Pain
Clinical narrative: Information has been received from a 58 year old female consumer with asthma and allergies to penicillin and erythromycin who five years ago (in November 2004), was vaccinated with the first dose of PNEUMOVAX 23. The patient had no reactions after the first vaccination. On 30-OCT-2009, the patient was received the second dose of an unspecified pneumonia shot (possibly PNEUMOVAX 23). Concomitant medication included "several medications" (detail not reported). Within six hours after receiving the second pneumonia vaccine, the consumer had severe chills for several hours, nausea and body aches. These symptoms were ongoing for about fourteen hours. During the week of 01-NOV-2009, the consumer had two to three episodes of nausea that lasted throughout the night and she was not eating. On 08-NOV-2009, 09-NOV-2009, and 13-NOV-2009, the patient experienced chills, body aches and nausea throughout the night. The consumer had felt a little better on 14-NOV-2009, 15-NOV-2009, and 16-NOV-2009 but not recovered. The patient mentioned that she was feeling nausea again during the phone call. It was also reported that the nausea was worse late in the day and into the evening or overnight. The patient did not have symptoms every day, they were had been sporadic in the last 18 days since receiving the pneumonia vaccine. The consumer also mentioned that she had received a seasonal flu vaccine (manufacturer unknown) two weeks prior to vaccination with the pneumonia shot and had no reactions. The patient made a call for medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 43.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a medical assistant concerning a 43 year old patient who on 13-NOV-2009 was vaccinated intramuscularly with a 0.5 mL dose of PNEUMOVAX 23. Subsequently, the patient experienced redness, warmth and swelling at the injection site. The patient visited the office for medical attention. No laboratory diagnostics studies were performed. At the time of the report, the outcome of the events was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 50.0
Sex: U
Vaccine: PPV
Symptoms: Erythema, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 50 year old patient who "this week", on approximately 15-NOV-2009, was vaccinated with a dose of PNEUMOVAX 23 (Lot # 665300/1214Y). The nurse reported that the day after being vaccinated, the patient developed redness from the shoulder to the elbow and fever. It was unspecified if the patient sought medical attention. At the time of the report, the patient's outcome was unspecified. Additional information was been requested. This is one of several cases reported by the same source.
Age: 49.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a medical assistant concerning a 49 year old patient who on 13-NOV-2009 was vaccinated intramuscularly with a 0.5 mL dose of PNEUMOVAX 23. Subsequently, the patient experienced redness, warmth and swelling at the injection site. The patient visited the office for medical attention. No laboratory diagnostics studies were performed. 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: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who on 17-NOV-2009, was vaccinated with the first dose of PNEUMOVAX 23 (lot# 664653/1337Y). Then the patient developed redness and soreness at the injection site. The patient would be seen in the clinic on 20-NOV-2009. At the time of the report, the outcome was unknown. Additional information has been requested. This is one of two reports received from the same source.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician assistant concerning a patient who "5 years ago" approximately in October 2004, was vaccinated with the first dose of PNEUMOVAX 23. Patient did not have any reactions after the first dose. In middle of October 2009 patient was vaccinated with the second dose of PNEUMOVAX 23 (lot # 664000/0621Y). Subsequently the patient experienced injection site reaction as bright red, swelling, painful that went from the top of the shoulder area almost to the top of the elbow all the way around the arm. At the time of reporting, the outcome of the events were unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Injection site erythema, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 58 year old female who on 16-NOV-2009 was vaccinated with a dose of PNEUMOVAX 23 (LOT# 664864/1365Y). Secondary suspect vaccination included an unspecified "seasonal flu vaccine" (name and manufacture unknown) which was received on the same day on different arm. On unspecified dates, the patient experienced symptoms like redness and swelling where the PNEUMOVAX 23 was given and also experienced headache, fever and nausea. Unspecified medical attention was sought and the patient's outcome was unknown. Follow up information has been received from the physician concerning this patient. It was confirmed that the patient received on 16-NOV-2009 a dose of PNEUMOVAX 23 (Lot # 664864/1365Y), IM, right deltoid, and a dose of FLUZONE, IM, left deltoid. Concomitant therapy included ALDACTAZIDE, verapamil, lorazepam, tiotropium bromide and PROVENTIL. The patient experienced on 17-NOV-2009 redness, vaccine site swelling, headache, fever and nausea. The patient recovered on unspecified date from all the adverse events. Additional information is not expected. This is one of the two reports from the same source.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 63 year old female patient who "within the past week", on approximately 08-NOV-2009, was vaccinated with a 0.5 mL dose of PNEUMOVAX 23 (Lot # 665300/1214Y). The nurse reported that the day after being vaccinated, the patient developed redness from the shoulder to the elbow with fever between 100-100.1 degrees. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unspecified. Additional information has been requested. This is one of several cases reported by the same source.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Rash
Clinical narrative: Information has been received from a medical assistant concerning an approximately 60 year old female who was vaccinated with a dose of PNEUMOVAX 23 on an unspecified date. Subsequently there was a "spot on the patient's arm and swelling that went down to the patient's elbow". At the time of the report, the outcome was unknown. No further information is available.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Information has been received from a nurse practitioner concerning a female with chronic obstructive pulmonary disease and diabetes who had received PNEUMOVAX 23 "multiple times in the past". In November 2009, "last week" the patient was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (lot # 664653/1337Y, 0.5ml). Subsequently the patient developed a "hot, tender, inflamed area" at the injection site. The patient was examined in the clinic and was diagnosed with cellulitis. The patient was prescribed an unspecified antibiotic. There was no laboratory test performed. At the time of the report, the outcome was unknown. Follow up information has been received from a physician concerning a 64 year old female patient with only chronic illness and no known drug allergies who on 10-NOV-2009 was vaccinated with a dose of PNEUMOVAX 23 (lot # 664653/1337Y) in her left deltoid. Subsequently the patient experienced local cellulitis. The patient was treated with KEFLEX 500mg 810x10, ULTRAM and MOTRIN. On 19-NOV-2009, follow up information noted that the patient was recovered. Follow up information has been received from the physician concerning a 64 year old female patient with chronic obstructive pulmonary disease, diabetes mellitus non-insulin-dependent, dyslipidaemia and no known drug allergies who on 10-NOV-2009 was vaccinated with the second dose of PNEUMOVAX 23 (lot # 664653/1337Y) in her left deltoid. On 11-NOV-2009 (previously reported as 10-NOV-2009) the patient experienced sterile cellulitis. On 12-NOV-2009 3x5 warm, erythema area below the deltoid was seen. The patient was treated with KEFLEX 500mg every 6 hours for 10 day, ULTRAM 50mg every 6 hours (duration not reported) and MOTRIN 800mg every 8 hours (duration not reported). At the time of the report, the patient had recovered. No further information is available. This is one of two reports received from the same source.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Skin warm
Clinical narrative: Information has been received from a nurse practitioner concerning a female with chronic obstructive pulmonary disease and diabetes who had received PNEUMOVAX 23 "multiple times in the past". In November 2009, "last week" the patient was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (lot # 664653/1337Y, 0.5ml). Subsequently the patient developed a "hot, tender, inflamed area" at the injection site. The patient was examined in the clinic and was diagnosed with cellulitis. The patient was prescribed an unspecified antibiotic. There was no laboratory test performed. At the time of the report, the outcome was unknown. Follow up information has been received from a physician concerning a 64 year old female patient with only chronic illness and no known drug allergies who on 10-NOV-2009 was vaccinated with a dose of PNEUMOVAX 23 (lot # 664653/1337Y) in her left deltoid. Subsequently the patient experienced local cellulitis. The patient was treated with KEFLEX 500mg 810x10, ULTRAM and MOTRIN. On 19-NOV-2009, follow up information noted that the patient was recovered. Follow up information has been received from the physician concerning a 64 year old female patient with chronic obstructive pulmonary disease, diabetes mellitus non-insulin-dependent, dyslipidaemia and no known drug allergies who on 10-NOV-2009 was vaccinated with the second dose of PNEUMOVAX 23 (lot # 664653/1337Y) in her left deltoid. On 11-NOV-2009 (previously reported as 10-NOV-2009) the patient experienced sterile cellulitis. On 12-NOV-2009 3x5 warm, erythema area below the deltoid was seen. The patient was treated with KEFLEX 500mg every 6 hours for 10 day, ULTRAM 50mg every 6 hours (duration not reported) and MOTRIN 800mg every 8 hours (duration not reported). At the time of the report, the patient had recovered. No further information is available. This is one of two reports received from the same source.
Sex: F
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who on 02-OCT-2009 was vaccinated with her first dose of PNEUMOVAX 23 (Lot number: 662839/1089X). The reporter mentioned that after administration of the vaccine the patient had an "unusual adverse reaction". At the time of reporting, reporter was requesting a lot check be conducted. It was unknown if the patient sought medical attention. Patient outcome has not been reported. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Injection site erythema, Injection site induration, Pain
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who on 17-NOV-2009 was vaccinated with her first dose of PNEUMOVAX 23 (Lot number: 662747/1086X). The reporter mentioned that 24 hours after administration of vaccine on 18-NOV-2009 the patient experienced a fever, chills, headache, body aches, redness and an induration at the injection site. At the time of reporting, reporter was requesting a lot check be conducted. It was unknown if the patient sought medical attention. Patient outcome has not been reported. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements and was released. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who on 17-NOV-2009 was vaccinated with her first dose of PNEUMOVAX 23 (Lot number: 662747/1086X). The reporter mentioned that 24 hours after administration of vaccine on 18-NOV-2009 the patient experienced a fever, chills, headache, body aches, redness and an induration at the injection site. At the time of reporting, reporter was requesting a lot check be conducted. It was unknown if the patient sought medical attention. Patient outcome has not been reported. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements and was released. Additional information has been requested.
Age: 1.11
Sex: U
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a consumer concerning her 13 month old child who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 instead of a PCV vaccine by mistake. No AE reported as a result. No further information was available at the time of this report. Follow-up information has been received via a telephone call from a medical assistant who indicated that the 13 month old child who on 23-NOV-2009 was vaccinated with the dose of PNEUMOVAX 23 (route not reported, LOT# 664556/1307Y). Concomitant vaccination included a dose of DAPTACEL (LOT# C3322AA, manufacturer Sanofi) on unspecified date. The medical assistant stated that the patient received PNEUMOVAX 23 instead of PREVNAR due to a medication error. The medical assistant also stated that the physician had written that the patient should receive the "Pneumonia vaccine". Follow-up information has been received from the physician who reported that the patient had no pre-existing allergies, birth defects nor medical conditions and that there was no illness at the time of vaccination. It was indicated that the patient who was on 23-NOV-2009 at 10:30 AM was vaccinated with the dose of PNEUMOVAX 23 (on left thigh, LOT# 664556/1307Y). Physician also noted that they gave PNEUMOVAX 23 instead of PREVNAR upset the mother of patient because they gave a shot that was not required. The patient did not experience any symptom signs and no adverse event. No further information is available.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Information has been received from a physician concerning a 67 year old female who on 19-NOV-2009 was vaccinated with a dose of PNEUMOVAX 23 (LOT# 664864/1365Y). On 20-NOV-2009 the patient experienced some injection site reaction like arm enlarged, hot to touch, swollen down to the elbow and redness. No further information is available at this time of the report. This is one of the two reports from the same source. Follow up information was received from a health professional concerning the patient with allergy to CATAPRESS patch who on 19-NOV-2009 was vaccinated with a first IM dose of PNEUMOVAX 23 (Lot No. 664864/1365Y) into her right deltoid at approximately 10:00 am. There was no illness at the time of vaccination. Concomitant vaccination included COREG, potassium chloride, NORVASC, therapy illegible, ALDACTONE, NIFEREX, EFFEXOR XR, aspirin, CALTRATE, ezetimibe (+) simvastatin (MSD), DIOVAN HCT, VICODIN, alendronate sodium (MSD) and cholecalciferol. In October 2009, the patient was vaccinated with a dose of influenza virus split virion 3v vaccine inactivated (manufacturer unspecified). On 20-NOV-2009 the patient experienced redness and swelling at the vaccination site. The patient also experienced itching. The patient's arm was swollen to the elbow joint. There was no fever. At the time of the report, the patient recovered on an unknown date. No further information is available.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: Information has been received from a health professional concerning a 48 year old female patient with penicillin and doxycycline allergy who on 28-OCT-2009 was vaccinated with a first SQ dose of PNEUMOVAX 23 (665300/1314Y) in her right arm and a fourth IM dose of FLUZONE (Lot No. U3195AA) in her left arm. The patient experienced dizziness at the time of vaccination. On 30-OCT-2009 the patient experienced right arm redness, swelling and tenderness. The patient was recommended ice and BENADRYL. On an unknown date the patient recovered. This is one of several reports received from the same source. No further information is available.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a licensed practical nurse concerning a 67 year old female patient who on 06-OCT-2009 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 662841/0626Y) SC, right arm. Concomitant therapy included FLUZONE. The nurse stated that on 08-OCT-2009 the patient's right arm was red, warm at touch and swollen at injection site. Patient was instructed to apply a cold pack, and took BENADRYL (dose and duration not reported). Unspecified medical attention was sought. At the time of this report the patient had recovered. Additional information is not expected.
Age: 6.0
Sex: F
Vaccine: PPV
Symptoms: Local reaction
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old female with asthma and drug hypersensitivity to ZITHROMAX who on 21-DEC-2009 was vaccinated intramuscularly with the fourth 0.5 mL dose of PNEUMOVAX 23 (LOT# 664000/0621Y). There was no concomitant medication. The patient was received the first dose of PNEUMOVAX 23 on 01-DEC-2003. On 22-DEC-2009 the patient experienced local reaction in the right deltoid area. The patient was seen in an office and was given BENADRYL. The lab was not performed. At this time of reporting, the patient was recovering. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a licensed practical nurse concerning a 68 year old female patient who on 30-SEP-2009 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 662841/0626Y) SC, left arm. Concomitant vaccination on the same day included a dose of FLUZONE (lot # U3195AA) IM, right deltoid. Subsequently, on 01-OCT-2009 the patient's left arm was red with a warm area at the injection site. The patient was told to apply cold pack and to take CLARITIN. At the time of the report, the patient recovered on an unspecified date. It was noted that the patient could not take BENADRYL. Additional information is not expected.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a late 70 year old male who on 18-DEC-2009 was vaccinated with a 0.5 mL dose of PNEUMOVAX 23 (LOT# 665402/1339Y). After vaccination, the patient experienced redness, swelling and itching around the elbow on the arm where the patient received the vaccine. The patient was seen by a nurse and was treated with antibiotic (manufacturer unknown) and "DEPO". The patient was recovered on an unspecified date. This one of the two reports from the same source. Follow-up information has been received from the Registered Nurse, concerning the 71 year old male patient, with no illness at time of vaccination and no known allergies, who on 14-DEC-2010 at 10:15 am (also reported as 18-DEC-2009), was vaccinated intramuscularly in the left deltoid with a dose of PNEUMOVAX 23. The nurse stated that on "16-DEC-2010" at 1:00 pm, the patient had the upper left arm red, itching and swelling. The reporter stated that the physician wrote no sign of infection. Patient was prescribed with antibiotic, pain and allergy medication. No further information is available.
Age: 59.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Information has been received from a licensed practical nurse concerning a 59 year old male patient who on 05-OCT-2009 was vaccinated subcutaneously with a dose of PNEUMOVAX 23 (lot# 662841/0626Y) into his left arm. Concomitant therapy included "influenza" (manufacturer, Sanofi, lot# U3195AP) which was administered intramuscularly into his right deltoid on 05-OCT-2009. Subsequently (also reported on 07-SEP-2009) the patient experienced left arm red and warm area. The patient told doctor that he did not have cold pack and had taken BENADRYL. The patient did not seek medical attention. On an unspecified date, the patient had recovered. Follow-up information has been received from the licensed practical nurse who stated that the AE onset date was 07-OCT-2009 and not on 07-SEP-2009 as previously reported. Additional information is not expected.
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Myalgia
Clinical narrative: Information has been received from a pharmacist concerning an 87 year old female patient who was vaccinated with a dose of PNEUMOVAX 23 (lot# 664871/1142Y) at the end of September 2009. On an unspecified date, the patient experienced arm "muscle" pain at the injection site. The dose of PNEUMOVAX 23 was administered at an unspecified clinic in another state from this pharmacy. There were no lab diagnostics studies performed. At the time of the report, the patient had not recovered. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Injection site induration
Clinical narrative: Information has been received from a pharmacist concerning a patient who on 07-DEC-2009 was vaccinated with a 0.5 mL first dose of PNEUMOVAX 23, subcutaneously. On the same day the patient developed an area of induration at the injection site of the abdomen. No laboratories studies performed. The patient sought unspecified medical attention. At the time of this report the patient had not recovered. Additional information is not expected.