chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Anxiety, Injection site rash, Local swelling, Swelling face, Throat irritation
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 37 year old female with asthma and latent tuberculosis and no drug reactions/allergies who on 21-OCT-2010 was vaccinated subcutaneously with 0.5 ml dose of PNEUMOVAX 23 (Lot# 665925) into right arm. Second suspect therapy included AFLURIA (M52008: 06/30/2011) (duration and dose not reported) administered at the time same but in the left arm. Other concomitant therapy included ZYRTEC. On 22-OCT-2010 the patient experienced a rash at injection site of right arm, and that morning upon arising, the patient experienced facial and neck swelling. Patient stated that she had had episodes of this happening after eating Mexican food. Patient also stated that her throat was scratchy and she felt anxious. The patient was seen in the nurse's office and the patient recovered from swelling, anxiety and scratchiness of her throat without treatment. The nurse reported that the patient had followed up with her allergist and would pursue further allergy testing in a month. No diagnostics study was performed. It was also reported that no rash was experienced at that injection site of AFLURIA. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pain, Rash, Vaccination complication
Clinical narrative: Information has been received concerning a female consumer who on 26-OCT-2010 was vaccinated with PNEUMOVAX 23 by a pharmacist at an off site vaccine clinic sponsored by the consumer's employer and had an adverse reaction to the pneumonia vaccine, which was a severe rash, extreme soreness, and approximately 3 inches in diameter spidering down arm. The pneumonia shot was administered correctly and according to protocol. At the time of this report, the outcome was unknown. It was unknown, if the patient sought medical attention. Additional information is expected.
Sex: M
Vaccine: PPV
Symptoms: Contusion, Erythema, Nausea, Pyrexia, Swelling
Clinical narrative: Information has been received from a male consumer who on 26OCT10 was vaccinated with a dose of PNEUMOVAX 23 by a pharmacist. The shot was administered correctly and according to protocol. The patient stated that he had a reaction from the PNEUMOVAX 23 with the following symptoms: bruising, swelling, redness, fever of 101, felt nauseous, and vomiting. It is unknown if the patient sought medical attention. At the time of reporting the patient's outcome and causality were unknown. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Information has been received from a male consumer who on 26OCT10 was vaccinated with a dose of PNEUMOVAX 23 by a pharmacist. The shot was administered correctly and according to protocol. The patient stated that he had a reaction from the PNEUMOVAX 23 with the following symptoms: bruising, swelling, redness, fever of 101, felt nauseous, and vomiting. It is unknown if the patient sought medical attention. At the time of reporting the patient's outcome and causality were unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Bone pain, Chills, Injection site erythema, Injection site mass
Clinical narrative: Information has been received regarding a female consume who on 26-OCT-2010 was given a dose of PNEUMOVAX 23 by a pharmacist at an off-site vaccine clinic. The vaccine was reportedly administered correctly and according to protocol. The customer had an adverse reaction to the vaccine. The symptoms were aches in leg and hip bones, extreme chills and shakes, red spots at injection site with a small lump lasting two days, and the redness was 3 inches in diameter and warm and red to the touch. At the time of the report, the outcome of the events was unknown. It was not specified whether the patient sought medical attention. Additional information is expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Pain in extremity, Tremor
Clinical narrative: Information has been received regarding a female consume who on 26-OCT-2010 was given a dose of PNEUMOVAX 23 by a pharmacist at an off-site vaccine clinic. The vaccine was reportedly administered correctly and according to protocol. The customer had an adverse reaction to the vaccine. The symptoms were aches in leg and hip bones, extreme chills and shakes, red spots at injection site with a small lump lasting two days, and the redness was 3 inches in diameter and warm and red to the touch. At the time of the report, the outcome of the events was unknown. It was not specified whether the patient sought medical attention. Additional information is expected.
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chills, Fatigue, Injection site erythema, Nausea
Clinical narrative: Information has been received from a female consumer who on 26OCT2010 was vaccinated with a dose of PNEUMOVAX 23 by a pharmacist. It was reported that the consumer had been administered the vaccine and suffered from soreness in arm, fever of 102 degrees, nausea, severe chills, 2-3 blotches of redness at the injection site, tiredness, and weakness. It was reported that the pneumonia shot was administered correctly and according to protocol. At the time of this report, the outcome was unknown. Additional information is expected.
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia, Rash macular
Clinical narrative: Information has been received from a female consumer who on 26OCT2010 was vaccinated with a dose of PNEUMOVAX 23 by a pharmacist. It was reported that the consumer had been administered the vaccine and suffered from soreness in arm, fever of 102 degrees, nausea, severe chills, 2-3 blotches of redness at the injection site, tiredness, and weakness. It was reported that the pneumonia shot was administered correctly and according to protocol. At the time of this report, the outcome was unknown. Additional information is expected.
Age: 51.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Oedema peripheral, Paraesthesia, Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a 51 year old male who on 22-OCT-2010 was vaccinated (IM, right arm) with PNEUMOVAX 23 (lot # 665708/0651Z, expiration date 15-JUN-2011). Secondary suspect therapy included seasonal influenza virus vaccine (manufacturer unspecified) received in the right arm on the same day. On 26-OCT-2010 the patient experienced fever 103F, chills, redness and swelling down the arm. The patient was seen at the office on 26-OCT-2010 and was treated with antibiotics. On 28-OCT-2010 the patient called the doctor in the morning to report his redness was receding but he still had swelling and had tingling in his fingers at that time. This is one of several reports received from the same source. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 50 year old female patient with iodine allergy, contrast dye allergy, hypothyroidism and type 2 diabetes mellitus, who in April 2010, was vaccinated with a first dose of PNEUMOVAX 23 (lot # unknown), 0.5 ml, subcutaneously. On 12-OCT-2010, the patient was vaccinated with a second dose of PNEUMOVAX 23, (lot # unknown), 0.5 ml, subcutaneously. Concomitant therapy included metformin, metoprolol, HUMULIN and SYNTHROID. The physician reported that, the patient developed redness, swelling and extreme pain of her right arm at the injection site. The arm pain extended from the patient's neck to her fingertips. The patient also received influenza virus vaccine (manufacturer unknown) (lot # unknown), in the same arm on 12-OCT-2010. The patient sought medical attention, an office visit. There were no laboratories diagnostic studies performed. At the time of the report, the patient was not recovered. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 10 weeks old male patient who on 27-OCT-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot # and expire date not reported) (route not reported). No adverse effect was known. Follow up information received from the registered nurse indicated that on 27-OCT-2010 at 12:45 pm, the patient was vaccinated with a first dose of PNEUMOVAX 23 (lot # 667418/0978Z), intramuscularly in her left thigh (low). Concomitant vaccination given on the same date included first doses of ROTATEQ (lot # 0521Y, lot number valid for MMR), oral; PEDIARIX (lot # ACZIB205AA), intramuscularly in her right thigh and ACTHIB (lot # UH167AA); intramuscularly in her left thigh (upper). It was reported that the patient did not develop any adverse reaction. The patient received a wrong medication (adult dose given to a child). The patient's outcome was unknown. Follow up information was received from a registered nurse who confirmed that the PNEUMOVAX 23 given to the 8 week old baby was a total human error. There was no product confusion involved. Additional information is not expected.
Age: 29.0
Sex: F
Vaccine: FLU3, PPV, TDAP, FLU3, PPV, TDAP
Symptoms: Cellulitis, Chills, Erythema, Injected limb mobility decreased, Malaise
Clinical narrative: Information has been received from a Registered Nurse concerning a 29 year old female patient with asthma, seasonal allergy and codeine allergy who on 27-SEP-2010 was vaccinated in the left deltoid with a 0.5 ml dose of PNEUMOVAX 23 (Lot# 665707/1407Y) (Expiration date: 12-JUN-2011). On 27-SEP-2010, the patient also received a dose of BOOSTRIX in the left deltoid and a dose of FLUZONE in the right deltoid. The nurse reported that on 29-SEP-2010, the patient reported sore left arm, which was difficult to raise, area of arm was red, warm and tender. She had fever, chills and malaise (reported as mailse). The patient was seen by physician on 29-SEP-2010, on 30-SEP-2010 and on 01-OCT-2010. Physician gave patient 1 gram of ROCEPHIN at each visit. Physician also prescribed patient AUGMENTIN to be taken orally for 10 days. There were no laboratory tests or diagnostic studies performed. At the time of the report, the patient had not recovered. Follow up information has been received from the registered nurse. It was reported that on 27-SEP-2010 the patient with no birth defects was vaccinated with the first dose of PNEUMOVAX 23 (Lot# 665707/1407Y) in the left deltoid. On the same date the patient received a dose of BOOSTRIX into the left arm and a dose of FLUZONE (unspecified) into the right arm. At the time of vaccination the patient presented asthma. On 28-SEP-2010 the patient developed red, warm and very sore left arm after the injections. The patient was diagnosed with cellulitis. The patient required 3 daily doses of ROCEPHIN 1 gram IM and AUGMENTIN 85 mg BID for 10 days to resolve. On an unspecified date the patient recovered. Cellulitis was considered to be other important medical event by the registered nurse. Follow up information has been received from a registered nurse who indicated that the patient was a 29 year old housewife with allergic rhinitis who on 27-SEP-2010 was vaccinated IM with the first doses of BOOSTRIX (lot # AC52BO51AB) in the left deltoid and a dose of FLUZONE (lot # UF201AA) in the right deltoid. On 28-SEP-2010, the patient's left arm became red, warm and very tender. A diagnosis of cellulitis of the left arm was done. An IM dose of ROCEPHIN and AUGMENTIN oral were given on 29-SEP-2010. A second dose of ROCEPHIN was given on 30-SEP-2010, cellulitis had increased. On 01-OCT-2010, the patient was feeling better, a third dose of ROCEPHIN was given. The patient recovered on 02-OCT-2010. The patient required doctor visit. Follow up information has been received from a registered nurse who stated that the patient required multiple doctor's visits at which she was administered IM ROCEPHIN but did not receive anything IV. Additional information is not expected.
Age: 29.0
Sex: F
Vaccine: FLU3, PPV, TDAP, FLU3, PPV, TDAP
Symptoms: Pain in extremity, Pyrexia, Skin warm, Tenderness
Clinical narrative: Information has been received from a Registered Nurse concerning a 29 year old female patient with asthma, seasonal allergy and codeine allergy who on 27-SEP-2010 was vaccinated in the left deltoid with a 0.5 ml dose of PNEUMOVAX 23 (Lot# 665707/1407Y) (Expiration date: 12-JUN-2011). On 27-SEP-2010, the patient also received a dose of BOOSTRIX in the left deltoid and a dose of FLUZONE in the right deltoid. The nurse reported that on 29-SEP-2010, the patient reported sore left arm, which was difficult to raise, area of arm was red, warm and tender. She had fever, chills and malaise (reported as mailse). The patient was seen by physician on 29-SEP-2010, on 30-SEP-2010 and on 01-OCT-2010. Physician gave patient 1 gram of ROCEPHIN at each visit. Physician also prescribed patient AUGMENTIN to be taken orally for 10 days. There were no laboratory tests or diagnostic studies performed. At the time of the report, the patient had not recovered. Follow up information has been received from the registered nurse. It was reported that on 27-SEP-2010 the patient with no birth defects was vaccinated with the first dose of PNEUMOVAX 23 (Lot# 665707/1407Y) in the left deltoid. On the same date the patient received a dose of BOOSTRIX into the left arm and a dose of FLUZONE (unspecified) into the right arm. At the time of vaccination the patient presented asthma. On 28-SEP-2010 the patient developed red, warm and very sore left arm after the injections. The patient was diagnosed with cellulitis. The patient required 3 daily doses of ROCEPHIN 1 gram IM and AUGMENTIN 85 mg BID for 10 days to resolve. On an unspecified date the patient recovered. Cellulitis was considered to be other important medical event by the registered nurse. Follow up information has been received from a registered nurse who indicated that the patient was a 29 year old housewife with allergic rhinitis who on 27-SEP-2010 was vaccinated IM with the first doses of BOOSTRIX (lot # AC52BO51AB) in the left deltoid and a dose of FLUZONE (lot # UF201AA) in the right deltoid. On 28-SEP-2010, the patient's left arm became red, warm and very tender. A diagnosis of cellulitis of the left arm was done. An IM dose of ROCEPHIN and AUGMENTIN oral were given on 29-SEP-2010. A second dose of ROCEPHIN was given on 30-SEP-2010, cellulitis had increased. On 01-OCT-2010, the patient was feeling better, a third dose of ROCEPHIN was given. The patient recovered on 02-OCT-2010. The patient required doctor visit. Follow up information has been received from a registered nurse who stated that the patient required multiple doctor's visits at which she was administered IM ROCEPHIN but did not receive anything IV. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased
Clinical narrative: Information was received from a female consumer who on 16OCT2010 was vaccinated with a dose of PNEUMOVAX 23, lot 665904/0866Z, "with an expiration date of 04JUL2011. It was reported that the consumer had an adverse reaction to the pneumonia shot about one hour after receiving it and experienced "arm froze up and she was unable to use it." The outcome was not reported. Additional information is expected.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 72 year old female patient with allergy to KEFLEX, who on 06-NOV-2010 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (Lot # 667405/0884Z) in right deltoid at the local emergency room. On 06-NOV-2010 the patient experienced local erythema and was treated with CEFTAZ and went home with AUGMENTIN orally. The next day on 07-NOV-2010, she returned to the emergency room when the erythema spread down her arm and was treated with vancomycin and BACTRIM. At the time of the report the outcome of the patient was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Limb discomfort, Mobility decreased, Oedema peripheral
Clinical narrative: Information has been received from a registered pharmacist concerning a 67 year old female patient who on 09-NOV-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot #664864/1365Y  Exp 03/24/2011), IM, in her right arm, at approximately 9:00 AM. Concomitant therapy included FLUVIRIN given on 09-NOV-2010, in her left arm at approximately 9:00 AM, lisinopril (Manufacturer unknown) and metformin. The pharmacist stated that by "early that afternoon she began to experience some discomfort" in her right arm and by that evening she had noted her right arm was throbbing, red, swollen, painful to the touch, with reduced mobility. Patient took a ALEVE that evening which did not help with the symptoms. At the time of reporting, the patient had not recovered. It was also reported that on unspecified date the patient had previously received a dose PNEUMOVAX 23 with "no problems". No problem had been noted in her left arm. The patient sought unspecified medical attention. Follow up information has been received from the registered pharmacist concerning the 67 year old female patient with no illness at time of vaccination who on 09-NOV-2010 was vaccinated IM into the right deltoid with a dose of PNEUMOVAX 23 at 8:30 AM at pharmacy. The patient returned to pharmacy the next morning with achy swollen red arm that was warm to the touched with throbbing pain and decreased mobility. Onset of symptoms was only a few hours. The patient was evaluated for cellulitis given KEFLEX and a steroid shot. The patient's adverse event required emergency room/doctor visit. On an unspecified date, the patient's adverse event recovered. No further information is available.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Skin warm
Clinical narrative: Information has been received from a registered pharmacist concerning a 67 year old female patient who on 09-NOV-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot #664864/1365Y  Exp 03/24/2011), IM, in her right arm, at approximately 9:00 AM. Concomitant therapy included FLUVIRIN given on 09-NOV-2010, in her left arm at approximately 9:00 AM, lisinopril (Manufacturer unknown) and metformin. The pharmacist stated that by "early that afternoon she began to experience some discomfort" in her right arm and by that evening she had noted her right arm was throbbing, red, swollen, painful to the touch, with reduced mobility. Patient took a ALEVE that evening which did not help with the symptoms. At the time of reporting, the patient had not recovered. It was also reported that on unspecified date the patient had previously received a dose PNEUMOVAX 23 with "no problems". No problem had been noted in her left arm. The patient sought unspecified medical attention. Follow up information has been received from the registered pharmacist concerning the 67 year old female patient with no illness at time of vaccination who on 09-NOV-2010 was vaccinated IM into the right deltoid with a dose of PNEUMOVAX 23 at 8:30 AM at pharmacy. The patient returned to pharmacy the next morning with achy swollen red arm that was warm to the touched with throbbing pain and decreased mobility. Onset of symptoms was only a few hours. The patient was evaluated for cellulitis given KEFLEX and a steroid shot. The patient's adverse event required emergency room/doctor visit. On an unspecified date, the patient's adverse event recovered. No further information is available.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a Doctor of Pharmacy concerning an approximately 70 year old male with gastrooesophageal reflux disease, hyperlipidemia and hypertension and a history of pulmonary embolism with not known drug allergies or reactions, who was vaccinated with two 0.5 ml doses of PNEUMOVAX 23, on 05-JUN-2005 and on 15-NOV-2010 (routes unspecified) (Lot#667405/0884Z, expiration date December 2011). Concomitant therapy included omeprazole, simvastatin, temazepam, vitamins (unspecified), omega-3 marine triglycerides, vitamin D (unspecified) and irbesartan. Pharmacist reported that on an unspecified date, (on approximately 15-NOV-2010) after receiving a dose of PNEUMOVAX 23, the patient experienced injection site reaction of severe cellulitis and was hospitalized (date unspecified). Subsequently the patient was treated with antimicrobials (unspecified). It was unspecified if the patient had experienced an adverse event with the dose of PNEUMOVAX 23 received on 05-JUN-2005. At the time of the report patient's outcome was not reported. Follow-up information has been received from a Doctor of Pharmacy and a nurse. The pharmacist confirmed that the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number 667405/0884Z, also confirmed by the administering nurse) on 15-NOV-2010. It was reported that the patient had injection site cellulitis and was hospitalized. The pharmacist did not know the patient's hospitalization dates. The pharmacist stated that she thought that the patient had recovered because there were no further scheduled patient follow-up appointments. The pharmacist could not definitely report that the patient had recovered. A standard lot check 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 of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning a 41 year old female who on 22-NOV-2010 was vaccinated intradermally with PNEUMOVAX 23 (lot number 665904/0866Z, expiration date 04-JUL-2011) instead of the Purified Protein Derivative (PPD) skin test. Concomitant therapy included MOTRIN. The patient currently had an injection site reaction. The nurse who gave the PNEUMOVAX 23 stated that the PNEUMOVAX 23 and PPD skin test looked the same to her. The patient sought medical attention by office visit. At time of the report, the patient was not recovered from injection site reaction. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site induration, Injection site infection, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a certified medical assistant concerning a patient who on 11-NOV-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot# 667271/0880Z) (Exp date 11-DEC-2011), SQ. The healthcare worker reported that the patient experienced infection at the injection site "including cellulitis", which was treated with antibiotics. At the time of the report the patient had recovered. The patient may have been treated in the emergency room. Due to the high number of adverse events, the reporter requested a lot check for lot# 667271/0880Z. The patient sought unspecified medical attention. Follow-up information was received from a certified medical assistant, regarding a 67 year-old male patient (65.5" and 178 lbs.) with (physical) lump in the middle of his chest, osteoarthritis, tinnitus, hearing loss, malignant neoplasm of prostate, esophagitis, hematuria, cervicalgia, rupture of rotator cuff and diverticulosis and with a history of prior immunizations: influenza (12-NOV-2001), pneumococcal polysaccharide (16-NOV-2001), tetanus (26-JUN-2005) and herpes zoster (shingles) (23-FEB-2009). Outpatient medications as of 01-DEC-10 (start dates not specified): aspirin EC, 81 mg, QD; LIPITOR, 10mg, HS; vitamin D, 2000 u QD. The patient was vaccinated on 11-NOV-10 at 8am with PNEUMOVAX 23 (lot# 667271/0880Z) in his left arm, subcutaneous. At the time of vaccination, the patient had a physical lump in the middle of his chest. It was reported that on 12-NOV-2010 at 9:16am, the patient had a dollar-sized mark where he had his pneumonia shot (left arm). The patient felt achy all over (from neck to his knees), and the area was hard and very sore. The patient was advised to continue to take over the counter pain reliever, massage the area and seek emergency room treatment for any difficulty in breathing. On 14-NOV-2010, the patient went to the emergency room with cellulitis. Treatment included stopping KEFLEX and starting BACTRIM DS and NORCO. It was unknown if the patient recovered. Follow-up information was received from the certified medical assistant who reported the patient was a male, 65.5 inches tall and 178 lbs. She reported that the patient was instructed to stop the KEFLEX once BACTRIM was started. The patient was also instructed to return to the emergency department for any fever, nausea or continued pain. The medical assistant also reported (in a letter to VAERS) that they have pulled the PNEUMOVAX 23 (lot# 0880Z) from use and have initiated an investigation, checking technique, syringes used and temperature of refrigerator. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports received from the same source. All medical records will be provided upon request. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Information has been received from a certified medical assistant concerning a patient who on 11-NOV-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot# 667271/0880Z) (Exp date 11-DEC-2011), SQ. The healthcare worker reported that the patient experienced infection at the injection site "including cellulitis", which was treated with antibiotics. At the time of the report the patient had recovered. The patient may have been treated in the emergency room. Due to the high number of adverse events, the reporter requested a lot check for lot# 667271/0880Z. The patient sought unspecified medical attention. Follow-up information was received from a certified medical assistant, regarding a 67 year-old male patient (65.5" and 178 lbs.) with (physical) lump in the middle of his chest, osteoarthritis, tinnitus, hearing loss, malignant neoplasm of prostate, esophagitis, hematuria, cervicalgia, rupture of rotator cuff and diverticulosis and with a history of prior immunizations: influenza (12-NOV-2001), pneumococcal polysaccharide (16-NOV-2001), tetanus (26-JUN-2005) and herpes zoster (shingles) (23-FEB-2009). Outpatient medications as of 01-DEC-10 (start dates not specified): aspirin EC, 81 mg, QD; LIPITOR, 10mg, HS; vitamin D, 2000 u QD. The patient was vaccinated on 11-NOV-10 at 8am with PNEUMOVAX 23 (lot# 667271/0880Z) in his left arm, subcutaneous. At the time of vaccination, the patient had a physical lump in the middle of his chest. It was reported that on 12-NOV-2010 at 9:16am, the patient had a dollar-sized mark where he had his pneumonia shot (left arm). The patient felt achy all over (from neck to his knees), and the area was hard and very sore. The patient was advised to continue to take over the counter pain reliever, massage the area and seek emergency room treatment for any difficulty in breathing. On 14-NOV-2010, the patient went to the emergency room with cellulitis. Treatment included stopping KEFLEX and starting BACTRIM DS and NORCO. It was unknown if the patient recovered. Follow-up information was received from the certified medical assistant who reported the patient was a male, 65.5 inches tall and 178 lbs. She reported that the patient was instructed to stop the KEFLEX once BACTRIM was started. The patient was also instructed to return to the emergency department for any fever, nausea or continued pain. The medical assistant also reported (in a letter to VAERS) that they have pulled the PNEUMOVAX 23 (lot# 0880Z) from use and have initiated an investigation, checking technique, syringes used and temperature of refrigerator. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports received from the same source. All medical records will be provided upon request. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site swelling, Oedema peripheral
Clinical narrative: Information has been received from a healthcare worker concerning a patient who on unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot# 667271/0880Z). The healthcare worker reported that the patient experienced an injection site reaction of pain, swelling, and erythema, patient went to emergency room. At the time of the report the patient's outcome was unknown. Due to the high number of adverse events, the reporter requested a lot check for lot# 667271/0880Z. Follow up information received from a certified medical assistant via medical records indicated that the patient was a 65 year old female, with liver metastases, colon cancer diagnosed on 18-JUL-2008, osteoporosis, seasonal (fall allergies) and penicillin allergies (noted on 24-JUL-2008) and menopause, who on 15-NOV-2010 at 11:00 am was vaccinated with a first dose of PNEUMOVAX 23 (lot # 667271/0880Z), subcutaneously in her right arm. Concomitant therapy included calcium (unspecified) (+) vitamin D (unspecified), multivitamins (unspecified), vitamin B12 and BONIVA (stopped it in favor of a calcium supplement). The adverse events onset date began on evening of vaccination; the patient stated that her arm started to swell and her fingers became numb and tingling; the patient called the clinic on 10-NOV-2010 and stated that the swelling was getting worse, but the numbness and the tingling improved; no signs of fever, shortness of breath, chest pain or rash reported by the patient. The patient was advised to use ice for swelling and come into the office to be seen. The patient did not want to; the patient was also advised to go to a walk-in clinic. On 17-NOV-2010, a registered nurse from the physician office called the patient and spoke to the patient's husband and asked about a possible reaction to PNEUMOVAX 23; the patient's husband stated that she did not go to the urgent care as advised. The patient's husband was advised that the patient should come into clinic for evaluation if swelling was not going down and arm continued to be hot to touch. The reporter stated that the patient recovered on an unspecified date. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports received from the same source. No further information is available.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a healthcare worker concerning a patient who on unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot# 667271/0880Z). The healthcare worker reported that the patient experienced an injection site reaction of pain, swelling, and erythema, patient went to emergency room. At the time of the report the patient's outcome was unknown. Due to the high number of adverse events, the reporter requested a lot check for lot# 667271/0880Z. Follow up information received from a certified medical assistant via medical records indicated that the patient was a 65 year old female, with liver metastases, colon cancer diagnosed on 18-JUL-2008, osteoporosis, seasonal (fall allergies) and penicillin allergies (noted on 24-JUL-2008) and menopause, who on 15-NOV-2010 at 11:00 am was vaccinated with a first dose of PNEUMOVAX 23 (lot # 667271/0880Z), subcutaneously in her right arm. Concomitant therapy included calcium (unspecified) (+) vitamin D (unspecified), multivitamins (unspecified), vitamin B12 and BONIVA (stopped it in favor of a calcium supplement). The adverse events onset date began on evening of vaccination; the patient stated that her arm started to swell and her fingers became numb and tingling; the patient called the clinic on 10-NOV-2010 and stated that the swelling was getting worse, but the numbness and the tingling improved; no signs of fever, shortness of breath, chest pain or rash reported by the patient. The patient was advised to use ice for swelling and come into the office to be seen. The patient did not want to; the patient was also advised to go to a walk-in clinic. On 17-NOV-2010, a registered nurse from the physician office called the patient and spoke to the patient's husband and asked about a possible reaction to PNEUMOVAX 23; the patient's husband stated that she did not go to the urgent care as advised. The patient's husband was advised that the patient should come into clinic for evaluation if swelling was not going down and arm continued to be hot to touch. The reporter stated that the patient recovered on an unspecified date. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports received from the same source. No further information is available.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Chills, Erythema, Oedema peripheral, Pain
Clinical narrative: Information has been received from a nurse concerning a 69 year old female who on 01-DEC-2010 was vaccinated with the left deltoid with PNEUMOVAX 23 (lot number 667416/0956Z, expiration date 17-DEC-2011). The patient developed cellulitis after vaccination with PNEUMOVAX 23. On 02-DEC-2010 the patient was seen in the office and given doxycycline. On 03-DEC-2010 she was admitted to the hospital. At time of the report, the patient's outcome was unknown. This is one of several reports received from the same source. Follow-up information received from a registered nurse stated that the patient was a female with bronchitis at time of vaccination and allergies to penicillin, sulfa, erythromycin, gluten protein and mold. On 01-DEC-2010, the patient was given the second dose of PNEUMOVAX 23 vaccine. Concomitant therapy included ZANTAC, FLONASE, LUNESTA, alendronate sodium (MSD), SYNTHROID, LASIX, DITROPAN, trazodone HCl and RELAFEN. At that evening, the patient noted chills and aching. On 02-DEC-2010 morning, the patient was seen in clinic with arm red, warm, swollen with red streaking. The patient was diagnosed with cellulitis. No relevant diagnostic tests were performed. At time of the report, the patient was recovered. No further information is available.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Information has been received from a nurse concerning a 69 year old female who on 01-DEC-2010 was vaccinated with the left deltoid with PNEUMOVAX 23 (lot number 667416/0956Z, expiration date 17-DEC-2011). The patient developed cellulitis after vaccination with PNEUMOVAX 23. On 02-DEC-2010 the patient was seen in the office and given doxycycline. On 03-DEC-2010 she was admitted to the hospital. At time of the report, the patient's outcome was unknown. This is one of several reports received from the same source. Follow-up information received from a registered nurse stated that the patient was a female with bronchitis at time of vaccination and allergies to penicillin, sulfa, erythromycin, gluten protein and mold. On 01-DEC-2010, the patient was given the second dose of PNEUMOVAX 23 vaccine. Concomitant therapy included ZANTAC, FLONASE, LUNESTA, alendronate sodium (MSD), SYNTHROID, LASIX, DITROPAN, trazodone HCl and RELAFEN. At that evening, the patient noted chills and aching. On 02-DEC-2010 morning, the patient was seen in clinic with arm red, warm, swollen with red streaking. The patient was diagnosed with cellulitis. No relevant diagnostic tests were performed. At time of the report, the patient was recovered. No further information is available.
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Pruritus, Rash macular, Urticaria
Clinical narrative: Information has been received from a 79 male patient with prostatitis (not taking any medications for it), mold allergy, dust allergy, grass allergy, Penicillin allergy, Amoxicillin allergy and Lincomycin allergy who on approximately 08-JAN-2011, "Last Saturday" at 15:00 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck). Concomitant therapies included: Losartan potassium (manufacturer unknown), Omeprazole and Omeprazole (MSD). One day after vaccination, on approximately 09-JAN-2011, "This past Sunday", he started to itch and break out. It first started out as hives, and then they all joined together as a blotch and then they started to turn purple and now they itch really bad and burn. He had then all over his body. He called a Nurse Practitioner on Sunday and she said to taken BENADRYL and that did not help. He then went to see his doctor on Monday and he gave him a cortisone shot and prescribed him Prednisone. He stated that its not shingles. And it's definitely an allergy reaction. He also said he didn't known what it was. It seemed to be getting worse thought. When he got the shot on Saturday it was four of them that receiving it, he and his wife and two friends. Out of all of them he was the only one that had a reaction. Hopefully this Prednisone worked. Caller only provided NDC# 0006496341. Follow up information received from physician concerning a retired male patient with Penicillin allergy, FLAGYL allergy and Clindamycin allergy who on 08-JAN-2011 (previously reported as on approximately 08-JAN-2011) was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # and expire date not reported). Physician stated that on 10-JAN-2011, the patient experienced a diffuse and itchy rash that targeted extremities and generalized urticaria. Physician added that on 18-JAN-2011, the patient had recovered. Physician considered the allergic reaction to be an other important medical event. Additional information is not expected.
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Hypersensitivity, Rash generalised, Rash macular, Rash pruritic, Skin burning sensation
Clinical narrative: Information has been received from a 79 male patient with prostatitis (not taking any medications for it), mold allergy, dust allergy, grass allergy, Penicillin allergy, Amoxicillin allergy and Lincomycin allergy who on approximately 08-JAN-2011, "Last Saturday" at 15:00 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck). Concomitant therapies included: Losartan potassium (manufacturer unknown), Omeprazole and Omeprazole (MSD). One day after vaccination, on approximately 09-JAN-2011, "This past Sunday", he started to itch and break out. It first started out as hives, and then they all joined together as a blotch and then they started to turn purple and now they itch really bad and burn. He had then all over his body. He called a Nurse Practitioner on Sunday and she said to taken BENADRYL and that did not help. He then went to see his doctor on Monday and he gave him a cortisone shot and prescribed him Prednisone. He stated that its not shingles. And it's definitely an allergy reaction. He also said he didn't known what it was. It seemed to be getting worse thought. When he got the shot on Saturday it was four of them that receiving it, he and his wife and two friends. Out of all of them he was the only one that had a reaction. Hopefully this Prednisone worked. Caller only provided NDC# 0006496341. Follow up information received from physician concerning a retired male patient with Penicillin allergy, FLAGYL allergy and Clindamycin allergy who on 08-JAN-2011 (previously reported as on approximately 08-JAN-2011) was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # and expire date not reported). Physician stated that on 10-JAN-2011, the patient experienced a diffuse and itchy rash that targeted extremities and generalized urticaria. Physician added that on 18-JAN-2011, the patient had recovered. Physician considered the allergic reaction to be an other important medical event. Additional information is not expected.
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Skin discolouration, Urticaria
Clinical narrative: Information has been received from a 79 male patient with prostatitis (not taking any medications for it), mold allergy, dust allergy, grass allergy, Penicillin allergy, Amoxicillin allergy and Lincomycin allergy who on approximately 08-JAN-2011, "Last Saturday" at 15:00 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck). Concomitant therapies included: Losartan potassium (manufacturer unknown), Omeprazole and Omeprazole (MSD). One day after vaccination, on approximately 09-JAN-2011, "This past Sunday", he started to itch and break out. It first started out as hives, and then they all joined together as a blotch and then they started to turn purple and now they itch really bad and burn. He had then all over his body. He called a Nurse Practitioner on Sunday and she said to taken BENADRYL and that did not help. He then went to see his doctor on Monday and he gave him a cortisone shot and prescribed him Prednisone. He stated that its not shingles. And it's definitely an allergy reaction. He also said he didn't known what it was. It seemed to be getting worse thought. When he got the shot on Saturday it was four of them that receiving it, he and his wife and two friends. Out of all of them he was the only one that had a reaction. Hopefully this Prednisone worked. Caller only provided NDC# 0006496341. Follow up information received from physician concerning a retired male patient with Penicillin allergy, FLAGYL allergy and Clindamycin allergy who on 08-JAN-2011 (previously reported as on approximately 08-JAN-2011) was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # and expire date not reported). Physician stated that on 10-JAN-2011, the patient experienced a diffuse and itchy rash that targeted extremities and generalized urticaria. Physician added that on 18-JAN-2011, the patient had recovered. Physician considered the allergic reaction to be an other important medical event. Additional information is not expected.
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pruritus, Rash, Rash macular
Clinical narrative: Information has been received from a 79 male patient with prostatitis (not taking any medications for it), mold allergy, dust allergy, grass allergy, Penicillin allergy, Amoxicillin allergy and Lincomycin allergy who on approximately 08-JAN-2011, "Last Saturday" at 15:00 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck). Concomitant therapies included: Losartan potassium (manufacturer unknown), Omeprazole and Omeprazole (MSD). One day after vaccination, on approximately 09-JAN-2011, "This past Sunday", he started to itch and break out. It first started out as hives, and then they all joined together as a blotch and then they started to turn purple and now they itch really bad and burn. He had then all over his body. He called a Nurse Practitioner on Sunday and she said to taken BENADRYL and that did not help. He then went to see his doctor on Monday and he gave him a cortisone shot and prescribed him Prednisone. He stated that its not shingles. And it's definitely an allergy reaction. He also said he didn't known what it was. It seemed to be getting worse thought. When he got the shot on Saturday it was four of them that receiving it, he and his wife and two friends. Out of all of them he was the only one that had a reaction. Hopefully this Prednisone worked. Caller only provided NDC# 0006496341. Follow up information received from physician concerning a retired male patient with Penicillin allergy, FLAGYL allergy and Clindamycin allergy who on 08-JAN-2011 (previously reported as on approximately 08-JAN-2011) was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # and expire date not reported). Physician stated that on 10-JAN-2011, the patient experienced a diffuse and itchy rash that targeted extremities and generalized urticaria. Physician added that on 18-JAN-2011, the patient had recovered. Physician considered the allergic reaction to be an other important medical event. Additional information is not expected.
Age: 84.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Condition aggravated, Musculoskeletal pain
Clinical narrative: Information has been received from a registered pharmacist concerning an 84 year old male patient with hypertension and no known drug allergies who on 22-SEP-2010, was vaccinated IM with 0.5 ml dose of PNEUMOVAX 23 (Lot# 667134/0738Z). Concomitant therapy included "blood pressure and pain medications". The registered pharmacist reported that on 22-SEP-2010, the patient experienced excruciating shoulder pain after administration of PNEUMOVAX 23. Lab diagnostics studies were not performed. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Follow-up information has been from the registered pharmacist, concerning this patient, with a history of benign prostatic hyperplasia and pain management, with no illness at the time of vaccination, who on 22-SEP-2010 at 9:35 was vaccinated IM with 0.5 ml first dose of PNEUMOVAX 23 (Lot# 667134/0738Z) into the right arm. Concomitant vaccination on 22-SEP-2010 at 9:31 included the first dose of FLUZONE (Lot # U3575FA) IM into the left arm. On 22-SEP-2010 at 12 pm, the patient cited "unbearable" pain in the right shoulder. The patient went to ER where he was given MEDROL DOSEPAK and PERCOCET for pain. The patient already had shoulder issue and was currently on medications for. After follow up, with the physician, he found that the patient had right flare of bursitis for which he recommended cortisone shot. Subsequently, the patient recovered from the event. The physician stated that the event was unrelated to PNEUMOVAX 23. The physician mentioned that he also disclosed that the patient went home and washed his car. The patient required emergency room/doctor visit. Follow up information has been received from the registered pharmacist concerning the male patient. It was reported that the patient was vaccinated at a pharmacy and was treated with PERCOCET 5/325. No further information is available.