chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a physician concerning a 16 year old female student (weight 144 lb, height 63") with migraine headaches who on 01-MAY-2007 at 3 pm was vaccinated with the first dose of GARDASIL, injection in right arm and the second dose of hepatitis A virus vaccine (unspecified) (lot #1282F), injection in the left arm. Concomitant medication was not reported. On 02-MAY-2007 within 24 hours of vaccination with the first dose of hepatitis A (also reported as second dose), the patient developed left deltoid muscle pain, swelling and erythema. Within 48 hours, the patient developed numbness and diminished strength in the left hand. The patient sought medical attention (not further specified). On 07-MAY-2007, the patient recovered from the events. Additional follow up information has been received from a RN concerning the patient, who received the first dose of GARDASIL, lot #656050/0245U in the left deltoid (previously reported as right deltoid). At the same time she received the second dose of VAQTA (MSD), lot #656316/1282F and reported that "both were given in the left deltoid". Within 24 hours the patient experienced muscle pain, redness, and erythema in the left deltoid. On the second day she had numbness and diminished strength in left hand. The patient was seen in the office on 04-MAY-2007 and treated with prednisone, hydrocodone, and TYLENOL. On 07-MAY-2007 she was seen with warmth, tingling and pain to left elbow. There was no edema or induration, small amount of firmness in the muscle, full range of motion of arm. On 06-JUN-2007 these symptoms resolved. Additional follow up information was received from the patient's father, who stated that his daughter complained of pain at injection site after GARDASIL was given. The patient's physician provided her with BENADRYL. The patient continued to experience pain the next day and 2 days later the pain began to worsen. The physician gave her a "blast of prednisone". The patient's father reported that his daughter has had her "4th blast of prednisone" and has not recovered from the pain. He also reported that his daughter was having difficulty sleeping and was given hydrocodone so she could go to sleep. Additional informtion is not expected.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Muscular weakness, Myalgia, Pain in extremity
Clinical narrative: This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a physician concerning a 16 year old female student (weight 144 lb, height 63") with migraine headaches who on 01-MAY-2007 at 3 pm was vaccinated with the first dose of GARDASIL, injection in right arm and the second dose of hepatitis A virus vaccine (unspecified) (lot #1282F), injection in the left arm. Concomitant medication was not reported. On 02-MAY-2007 within 24 hours of vaccination with the first dose of hepatitis A (also reported as second dose), the patient developed left deltoid muscle pain, swelling and erythema. Within 48 hours, the patient developed numbness and diminished strength in the left hand. The patient sought medical attention (not further specified). On 07-MAY-2007, the patient recovered from the events. Additional follow up information has been received from a RN concerning the patient, who received the first dose of GARDASIL, lot #656050/0245U in the left deltoid (previously reported as right deltoid). At the same time she received the second dose of VAQTA (MSD), lot #656316/1282F and reported that "both were given in the left deltoid". Within 24 hours the patient experienced muscle pain, redness, and erythema in the left deltoid. On the second day she had numbness and diminished strength in left hand. The patient was seen in the office on 04-MAY-2007 and treated with prednisone, hydrocodone, and TYLENOL. On 07-MAY-2007 she was seen with warmth, tingling and pain to left elbow. There was no edema or induration, small amount of firmness in the muscle, full range of motion of arm. On 06-JUN-2007 these symptoms resolved. Additional follow up information was received from the patient's father, who stated that his daughter complained of pain at injection site after GARDASIL was given. The patient's physician provided her with BENADRYL. The patient continued to experience pain the next day and 2 days later the pain began to worsen. The physician gave her a "blast of prednisone". The patient's father reported that his daughter has had her "4th blast of prednisone" and has not recovered from the pain. He also reported that his daughter was having difficulty sleeping and was given hydrocodone so she could go to sleep. Additional informtion is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Asthenia, Dizziness, Lymphadenopathy, Pharyngolaryngeal pain
Clinical narrative: Information has been received from a physician concerning a 23 year old female with no allergies or medical history, who on 08-MAY-2007, was vaccinated IM into the right deltoid with 0.5 ml of the second dose of Gardasil.  Concomitant therapy included tetracycline (+) YASMIN.  In May 2007, the patient experienced acute pharyngitis, weakness, dizziness, and sore throat.  It was also reported that the patient  received the first and second doses 4 weeks apart.  Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Inappropriate schedule of drug administration, Pharyngitis
Clinical narrative: Information has been received from a physician concerning a 23 year old female with no allergies or medical history, who on 08-MAY-2007, was vaccinated IM into the right deltoid with 0.5 ml of the second dose of Gardasil.  Concomitant therapy included tetracycline (+) YASMIN.  In May 2007, the patient experienced acute pharyngitis, weakness, dizziness, and sore throat.  It was also reported that the patient  received the first and second doses 4 weeks apart.  Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Asthenia, Dizziness, Inappropriate schedule of drug administration, Pharyngitis, Pharyngolaryngeal pain
Clinical narrative: Information has been received from a physician concerning a 23 year old female with no allergies or medical history, who on 08-MAY-2007, was vaccinated IM into the right deltoid with 0.5 ml of the second dose of Gardasil.  Concomitant therapy included tetracycline (+) YASMIN.  In May 2007, the patient experienced acute pharyngitis, weakness, dizziness, and sore throat.  It was also reported that the patient  received the first and second doses 4 weeks apart.  Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Information has been received from a Certified Medical Assistant (C.M.A.) concerning a 19 year old female patient with depression who on 10-MAY-2007 was vaccinated IM in left deltoid with a dose of GARDASIL vaccine (yeast) lot #657006/0188U. Concomitant therapy included YASMIN AND LITHIUM. On 16-MAY-2007 patient called the office and reported that she had injection site rash following vaccination and noticed it on 13-MAY-2007, but could have been present earlier. The rash was described as red bumps around the injection site that were itchy. The rash had not changed since noticed on 13-MAY-2007. The patient was instructed to use BENADRYL. The patient's injection site rash persisted. Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2007. In follow up it was reported that the patient was advised to use BENADRYL and hydrocortisone acetate cream and let them know if that did not help. The patient recovered. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from a Certified Medical Assistant (C.M.A.) concerning a 19 year old female patient with depression who on 10-MAY-2007 was vaccinated IM in left deltoid with a dose of GARDASIL vaccine (yeast) lot #657006/0188U. Concomitant therapy included YASMIN AND LITHIUM. On 16-MAY-2007 patient called the office and reported that she had injection site rash following vaccination and noticed it on 13-MAY-2007, but could have been present earlier. The rash was described as red bumps around the injection site that were itchy. The rash had not changed since noticed on 13-MAY-2007. The patient was instructed to use BENADRYL. The patient's injection site rash persisted. Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2007. In follow up it was reported that the patient was advised to use BENADRYL and hydrocortisone acetate cream and let them know if that did not help. The patient recovered. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Rash
Clinical narrative: Information has been received from a nurse practitioner, concerning a 17 year old female who on 10-MAY-2007 was vaccinated IM, with the first dose of Gardasil. Following the vaccination, the patient felt dizzy while still in the physician's office; she sat down for 10 minutes and was fine. Later that day, 10-MAY-2007, she developed a rash on her legs; treatment with BENADRYL brought relief of the rash. The next morning, however, the rash also reappeared on her arms, and treatment with diphenhydramine again brought relief. The patient has had recurrence of rash "off and on" at different locations. At the time of this report, the outcome of the rash was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a nurse practitioner, concerning a 17 year old female who on 10-MAY-2007 was vaccinated IM, with the first dose of Gardasil. Following the vaccination, the patient felt dizzy while still in the physician's office; she sat down for 10 minutes and was fine. Later that day, 10-MAY-2007, she developed a rash on her legs; treatment with BENADRYL brought relief of the rash. The next morning, however, the rash also reappeared on her arms, and treatment with diphenhydramine again brought relief. The patient has had recurrence of rash "off and on" at different locations. At the time of this report, the outcome of the rash was unknown. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site nodule
Clinical narrative: Information has been received from a physician concerning a female who in April 2007, was vaccinated with the first dose of Gardasil. Subsequently the patient experienced a small lump, similar to a mosquito bite, on her left shoulder. As of 23-MAY-2007, the patient had not recovered. It was not known whether the second or third doses of vaccine would be administered. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a physician concerning a 24 year old female with no pertinent medical history or drug reactions/allergies who on 18-APR-2007 was vaccinated with the first dose of GARDASIL (lot# 657622/0388U) in the left deltoid IM at 10:30 AM. Subsequently the patient developed a small lump, similar to a mosquito bite, on her left shoulder. As of 23-MAY-2007, the patient had not recovered. It was not known whether the second or third doses of vaccine would be adminstered. Follow-up information was received. On 18-APR-2007 the patient also developed swelling at the site of injection and then developed a lump about three-quarters of a centimeter. Medical attention was sought. The patient recovered on an unspecified date in July 2007. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site swelling, Mass
Clinical narrative: Information has been received from a physician concerning a female who in April 2007, was vaccinated with the first dose of Gardasil. Subsequently the patient experienced a small lump, similar to a mosquito bite, on her left shoulder. As of 23-MAY-2007, the patient had not recovered. It was not known whether the second or third doses of vaccine would be administered. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a physician concerning a 24 year old female with no pertinent medical history or drug reactions/allergies who on 18-APR-2007 was vaccinated with the first dose of GARDASIL (lot# 657622/0388U) in the left deltoid IM at 10:30 AM. Subsequently the patient developed a small lump, similar to a mosquito bite, on her left shoulder. As of 23-MAY-2007, the patient had not recovered. It was not known whether the second or third doses of vaccine would be adminstered. Follow-up information was received. On 18-APR-2007 the patient also developed swelling at the site of injection and then developed a lump about three-quarters of a centimeter. Medical attention was sought. The patient recovered on an unspecified date in July 2007. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a 13 year old female with sulfonamide allergy who on 12-JAN-2007 was vaccinated with Gardasil (Lot number 653937/0637F) intramuscularly in the left arm. On approximately 12-JAN-2007 the patient experienced red bumpy rash, rash on arms, rash around breast and mouth also burned. On 14-MAR-2007, the patient was vaccinated with Gardasil vaccine (Lot number 655617/1447F) intramuscularly in the left arm. On 16-MAR-2007 the patient experienced red bumpy rash. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Erythema, Oral discomfort, Rash, Skin burning sensation
Clinical narrative: Information has been received from a licensed practical nurse concerning a 13 year old female with sulfonamide allergy who on 12-JAN-2007 was vaccinated with Gardasil (Lot number 653937/0637F) intramuscularly in the left arm. On approximately 12-JAN-2007 the patient experienced red bumpy rash, rash on arms, rash around breast and mouth also burned. On 14-MAR-2007, the patient was vaccinated with Gardasil vaccine (Lot number 655617/1447F) intramuscularly in the left arm. On 16-MAR-2007 the patient experienced red bumpy rash. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Pain in extremity, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 74 year old male patient with no medical history or allergies who on 18-MAY-2007 was vaccinated SC on the left arm with a dose of Zostavax (Oka/Merck) (Lot # 657559/0462U). There was no concomitant medication. On 20-MAY-2007 the patient complained of his right buttock area hurting and developed a rash on the right buttock on 23-MAY-2007. The patient was diagnosed with shingles. The patient was treated with acetaminophen (+) hydrocodone bitartrate (LORTAB) and famciclovir (FAMVIR). No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/14/2007. Information has been received from a registered nurse concerning a 74 year old male patient with no medical history or allergies who on 18-MAY-2007 at 10:07 AM was vaccinated SC on the left arm with a first 0.65 ml dose of ZOSTAVAX (Oka/Merck) (Lot # 657559/0462U), concomitant therapy included ALTACE. On 25-MAY-2007 the patient complained of his right buttock area hurting and developed a rash on the right buttock on 23-MAY-2007. The patient was diagnosed with shingles. The patient was treated with LORTAB and FAMVIR. No diagnostic laboratory testss were underaken. A product quality complaint was not involved. Additional information has been received from the patient's wife who stated that her husband developed shingles soon after vaccination and he went to the ER. At the time of report the patient was recovered. Additional information has been received from the registered nurse who stated that on 20-MAY-2007 the patient developed pain and rash on right buttocks, three days after vaccination. The physician diagnosed shingles on 24-MAY-2007. The patient was treated with FAMVIR 500 mg 1 times a day and LORTAB. No further information is expected.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Musculoskeletal pain
Clinical narrative: Information has been received from a registered nurse concerning a 74 year old male patient with no medical history or allergies who on 18-MAY-2007 was vaccinated SC on the left arm with a dose of Zostavax (Oka/Merck) (Lot # 657559/0462U). There was no concomitant medication. On 20-MAY-2007 the patient complained of his right buttock area hurting and developed a rash on the right buttock on 23-MAY-2007. The patient was diagnosed with shingles. The patient was treated with acetaminophen (+) hydrocodone bitartrate (LORTAB) and famciclovir (FAMVIR). No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/14/2007. Information has been received from a registered nurse concerning a 74 year old male patient with no medical history or allergies who on 18-MAY-2007 at 10:07 AM was vaccinated SC on the left arm with a first 0.65 ml dose of ZOSTAVAX (Oka/Merck) (Lot # 657559/0462U), concomitant therapy included ALTACE. On 25-MAY-2007 the patient complained of his right buttock area hurting and developed a rash on the right buttock on 23-MAY-2007. The patient was diagnosed with shingles. The patient was treated with LORTAB and FAMVIR. No diagnostic laboratory testss were underaken. A product quality complaint was not involved. Additional information has been received from the patient's wife who stated that her husband developed shingles soon after vaccination and he went to the ER. At the time of report the patient was recovered. Additional information has been received from the registered nurse who stated that on 20-MAY-2007 the patient developed pain and rash on right buttocks, three days after vaccination. The physician diagnosed shingles on 24-MAY-2007. The patient was treated with FAMVIR 500 mg 1 times a day and LORTAB. No further information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Dyspnoea, Flushing, Food allergy, Laboratory test, Seasonal allergy
Clinical narrative: Information has been received from a physician and his office manager concerning a 17 years old female with no known drug allergies who on 25-MAY-2007 was vaccinated with the first 0.5 mL dose of Gardasil (lot # 657737/05220) and concomitant suspect therapy Menactra (lot #U2278AA). It was reported that the patient left the physician's office feeling fine after the vaccinations, although, approximately one hour later returned to the office with severe shortness of breath. The patient was diagnosed with an anaphylaxis reaction and was treated with one epinephrine (EPI-PEN) injection and unspecified steroids. Subsequently, the patient's breathing returned to normal, and the patient was considered recovered from the anaphylactic reaction. The patient was referred to an allergist, who will evaluate the event and attempt to determine the source of the patient's anaphylactic reaction. The Gardasil vaccination series will be "on hold" until results from the allergist are obtained. Anaphylactic reaction was considered to be disabling, immediately life-threatening and medically significant event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Skin test positive, Throat irritation, Throat tightness
Clinical narrative: Information has been received from a physician and his office manager concerning a 17 years old female with no known drug allergies who on 25-MAY-2007 was vaccinated with the first 0.5 mL dose of Gardasil (lot # 657737/05220) and concomitant suspect therapy Menactra (lot #U2278AA). It was reported that the patient left the physician's office feeling fine after the vaccinations, although, approximately one hour later returned to the office with severe shortness of breath. The patient was diagnosed with an anaphylaxis reaction and was treated with one epinephrine (EPI-PEN) injection and unspecified steroids. Subsequently, the patient's breathing returned to normal, and the patient was considered recovered from the anaphylactic reaction. The patient was referred to an allergist, who will evaluate the event and attempt to determine the source of the patient's anaphylactic reaction. The Gardasil vaccination series will be "on hold" until results from the allergist are obtained. Anaphylactic reaction was considered to be disabling, immediately life-threatening and medically significant event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Anaphylactic reaction, Dyspnoea
Clinical narrative: Information has been received from a physician and his office manager concerning a 17 years old female with no known drug allergies who on 25-MAY-2007 was vaccinated with the first 0.5 mL dose of Gardasil (lot # 657737/05220) and concomitant suspect therapy Menactra (lot #U2278AA). It was reported that the patient left the physician's office feeling fine after the vaccinations, although, approximately one hour later returned to the office with severe shortness of breath. The patient was diagnosed with an anaphylaxis reaction and was treated with one epinephrine (EPI-PEN) injection and unspecified steroids. Subsequently, the patient's breathing returned to normal, and the patient was considered recovered from the anaphylactic reaction. The patient was referred to an allergist, who will evaluate the event and attempt to determine the source of the patient's anaphylactic reaction. The Gardasil vaccination series will be "on hold" until results from the allergist are obtained. Anaphylactic reaction was considered to be disabling, immediately life-threatening and medically significant event. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site bruising, Injection site pruritus, Myalgia, Nausea, Pharyngolaryngeal pain
Clinical narrative: Information has been received from a registered nurse, concerning a 26 year old female patient, who on 14-MAY-2007 was vaccinated with the first dose, 0.5ml, IM, of Gardasil (invalid lot # provided). Concomitant therapy included ethinyl estradiol (+) etonogestrel (NUVARING). On 15-MAY-2007 the patient experienced "nausea, vomiting, myalgia, a sore throat, itching and bruising at the injection site." The following day, 16-MAY-2007, the patient recovered all of the events. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pruritus generalised, Vomiting
Clinical narrative: Information has been received from a registered nurse, concerning a 26 year old female patient, who on 14-MAY-2007 was vaccinated with the first dose, 0.5ml, IM, of Gardasil (invalid lot # provided). Concomitant therapy included ethinyl estradiol (+) etonogestrel (NUVARING). On 15-MAY-2007 the patient experienced "nausea, vomiting, myalgia, a sore throat, itching and bruising at the injection site." The following day, 16-MAY-2007, the patient recovered all of the events. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a registered nurse, concerning a 26 year old female patient, who on 14-MAY-2007 was vaccinated with the first dose, 0.5ml, IM, of Gardasil (invalid lot # provided). Concomitant therapy included ethinyl estradiol (+) etonogestrel (NUVARING). On 15-MAY-2007 the patient experienced "nausea, vomiting, myalgia, a sore throat, itching and bruising at the injection site." The following day, 16-MAY-2007, the patient recovered all of the events. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 22-MAY-2007 was vaccinated with Gardasil. On 22-MAY-2007 it was reported that the patient experienced "a serious episode of fainting" after her first administration of Gardasil. The patient sought unspecified medical attention. No other information was available. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female who on approximately 01-MAY-2007 was vaccinated with Gardasil. Since the vaccination, the patient has experienced arm pain. The arm pain has persisted. Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 6/14/2007; 10/8/2007. Information has been received from a registered nurse concerning a 20 year old female with no pertinent medical history or drug reactions/allergies who on 08-MAY-2007 was vaccinated with a first dose of GARDASIL (657622/0388U) 0.5 mL injection in the left deltoid. Since the vaccination, the patient has experienced arm pain. Medical attention was sought. At the time of reporting the patient had not recovered. Additional information was not provided. Follow-up information was received from a registered nurse. The site hurt initially but the discomfort was gone 09-MAY-2007. The site began hurting again one week later and the patient called the office and was instructed to use warm compresses, TYLENOL or ADVIL and to call back. The patient denied any redness at the site and denied having fever. The patients arm did feel better but became very sore on 27-MAY-2007. The arm hurts more at night than during the day. The patient reports that she cannot lift her arm above her head and getting dressed is difficult. She feels fine otherwise. No further work-up was done. On an unspecified date the arm discomfort resolved spontaneously and the patient recovered. Further information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female who on approximately 01-MAY-2007 was vaccinated with Gardasil. Since the vaccination, the patient has experienced arm pain. The arm pain has persisted. Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 6/14/2007; 10/8/2007. Information has been received from a registered nurse concerning a 20 year old female with no pertinent medical history or drug reactions/allergies who on 08-MAY-2007 was vaccinated with a first dose of GARDASIL (657622/0388U) 0.5 mL injection in the left deltoid. Since the vaccination, the patient has experienced arm pain. Medical attention was sought. At the time of reporting the patient had not recovered. Additional information was not provided. Follow-up information was received from a registered nurse. The site hurt initially but the discomfort was gone 09-MAY-2007. The site began hurting again one week later and the patient called the office and was instructed to use warm compresses, TYLENOL or ADVIL and to call back. The patient denied any redness at the site and denied having fever. The patients arm did feel better but became very sore on 27-MAY-2007. The arm hurts more at night than during the day. The patient reports that she cannot lift her arm above her head and getting dressed is difficult. She feels fine otherwise. No further work-up was done. On an unspecified date the arm discomfort resolved spontaneously and the patient recovered. Further information is not expected.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Burning sensation, Pain, Paraesthesia, Pruritus
Clinical narrative: Information has been received from a consumer concerning her 79 year old mother who on approximately 10-MAY-2007 was vaccinated with a 0.65 ml dose of Zostavax (Oka/Merck). On approximately 17-MAY-2007 the patient broke out in a rash of shingles. At the time of the report the patient had not recovered. Medical attention was not sought. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Tenderness
Clinical narrative: Information has been received from a consumer concerning her 79 year old mother who on approximately 10-MAY-2007 was vaccinated with a 0.65 ml dose of Zostavax (Oka/Merck). On approximately 17-MAY-2007 the patient broke out in a rash of shingles. At the time of the report the patient had not recovered. Medical attention was not sought. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer concerning her 79 year old mother who on approximately 10-MAY-2007 was vaccinated with a 0.65 ml dose of Zostavax (Oka/Merck). On approximately 17-MAY-2007 the patient broke out in a rash of shingles. At the time of the report the patient had not recovered. Medical attention was not sought. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Information has been received from a physician, concerning a 17 year old female patient (a student), with a drug hypersensitivity to Benzaclin, who on 15-MAY-2007, at 4:15pm was vaccinated in right arm with the first dose of Gardasil (Lot #656371/0181U). Concomitant therapy involved an ear irrigation at the visit, and also included Adacel (Lot#C2632AA), Zyrtec and vitamins (unspecified manufacturer, over the counter). There was no illness at the time of vaccination. The physician reported that the patient "seemed fine" immediately after the vaccine was administered, but at 4:30pm, when she was checking out, she felt lightheaded and passed out, "fainted and almost hit her head on the counter;" she was unconscious for a few seconds. The physician noted that the patient had a low blood pressure (not specified), and a low pulse rate (not specified). The patient was taken to the emergency room for evaluation an electrocardiogram result was normal, blood pressure was 128/79, and pulse oximetry was 80%. She was diagnosed with "presumed vasovagal syncope, " and was released. The physician confirmed that the patient had recovered on the same day, 15-MAY-2007, but also specified she had recovered within 24 hours. The physician considered the event of "fainted and almost hit her head on the counter," to be disabling/incapacitating, and an other important medical event. Additional information has been requested. Follow up information indicated the physician considered the event of "fainted and almost hit her head on the counter," to be serious only as an other important medical event (previously reported also as disabling/incapacitating). No further information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Dizziness, Electrocardiogram normal, Heart rate decreased, Hypotension, Loss of consciousness
Clinical narrative: Information has been received from a physician, concerning a 17 year old female patient (a student), with a drug hypersensitivity to Benzaclin, who on 15-MAY-2007, at 4:15pm was vaccinated in right arm with the first dose of Gardasil (Lot #656371/0181U). Concomitant therapy involved an ear irrigation at the visit, and also included Adacel (Lot#C2632AA), Zyrtec and vitamins (unspecified manufacturer, over the counter). There was no illness at the time of vaccination. The physician reported that the patient "seemed fine" immediately after the vaccine was administered, but at 4:30pm, when she was checking out, she felt lightheaded and passed out, "fainted and almost hit her head on the counter;" she was unconscious for a few seconds. The physician noted that the patient had a low blood pressure (not specified), and a low pulse rate (not specified). The patient was taken to the emergency room for evaluation an electrocardiogram result was normal, blood pressure was 128/79, and pulse oximetry was 80%. She was diagnosed with "presumed vasovagal syncope, " and was released. The physician confirmed that the patient had recovered on the same day, 15-MAY-2007, but also specified she had recovered within 24 hours. The physician considered the event of "fainted and almost hit her head on the counter," to be disabling/incapacitating, and an other important medical event. Additional information has been requested. Follow up information indicated the physician considered the event of "fainted and almost hit her head on the counter," to be serious only as an other important medical event (previously reported also as disabling/incapacitating). No further information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Loss of consciousness, Syncope, Syncope
Clinical narrative: Information has been received from a physician, concerning a 17 year old female patient (a student), with a drug hypersensitivity to Benzaclin, who on 15-MAY-2007, at 4:15pm was vaccinated in right arm with the first dose of Gardasil (Lot #656371/0181U). Concomitant therapy involved an ear irrigation at the visit, and also included Adacel (Lot#C2632AA), Zyrtec and vitamins (unspecified manufacturer, over the counter). There was no illness at the time of vaccination. The physician reported that the patient "seemed fine" immediately after the vaccine was administered, but at 4:30pm, when she was checking out, she felt lightheaded and passed out, "fainted and almost hit her head on the counter;" she was unconscious for a few seconds. The physician noted that the patient had a low blood pressure (not specified), and a low pulse rate (not specified). The patient was taken to the emergency room for evaluation an electrocardiogram result was normal, blood pressure was 128/79, and pulse oximetry was 80%. She was diagnosed with "presumed vasovagal syncope, " and was released. The physician confirmed that the patient had recovered on the same day, 15-MAY-2007, but also specified she had recovered within 24 hours. The physician considered the event of "fainted and almost hit her head on the counter," to be disabling/incapacitating, and an other important medical event. Additional information has been requested. Follow up information indicated the physician considered the event of "fainted and almost hit her head on the counter," to be serious only as an other important medical event (previously reported also as disabling/incapacitating). No further information is expected.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Dyspnoea, Swelling, Urticaria
Clinical narrative: Patient experienced swelling/ SOB, urticaria after Varivax vaccine. Patient was giving Benadryl 25mg PO and Nebulizer treatment with Albuterol for wheezing. Vitals stable.
Age: 0.08
Sex: F
Vaccine: RV5
Symptoms: Erythema, Mouth ulceration, Tinea infection
Clinical narrative: Information has been received from a physician concerning an approximately 6-week-old female who was vaccinated PO with the first 2.0 mL dose of Rotateq (lot number not provided). The physician reported that, two weeks after being vaccinated, the patient developed a small circular ulcer, 4 mL in diameter, on her soft palate characterized by a red border with a clear center at the back part of her throat. The physician noted that it looked like ring worm. Unspecified medical attention was sought and the patient was treated with nystatin. The patient subsequently recovered while on therapy. The physician considered the patient's ulcer to be an other important medical event as she was treated with nystatin. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Cough, Culture positive, Pertussis, Pertussis identification test positive, Vaccination failure
Clinical narrative: Initial report received from a health care professional on 31 May 2007. An 11 year old, male patient (with a history of asthma) developed cough after he received Adacel (lot number C2572AA) intramuscularly in the right arm on 26 October 2006. He did not have any illness at the time of the vaccination. On 17 May 2007, he was seen at the physician's office where a nasal pharyngeal culture was done to rule out pneumonia versus pertussis. On 25 May 2007, the report showed positive Bordetella pertussis. He was treated with Zithromax for 5 days and it was reported that he recovered.
Age: 36.0
Sex: F
Vaccine: JEV, RAB, TYP, JEV, RAB
Symptoms: Joint swelling, Urticaria
Clinical narrative: SEROUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. A 36-year-old female patient with no known medical history had received a subcutaneous right arm injection of JE-Vax (lot number EJN236A, a left arm injection of Typhim (lot number Z0479), and a intramuscular left arm injection of Rabavert (lot number 412011A). On 07 May 2007 the patient received a dose of Typhim (she had received "one or two" previous doses). On 22 May 2007, she received her third dose of JE-Vax and first dose of Rabavert. On 29 May 2007 the patient received her fourth dose of JE-Vax and second dose of Rabavert. Approximately 72 hours later, on 01 June 2007, she developed acute generalized severe urticaria in addition to small and large joint swelling. The patient presented to the emergency department and was treated with intramuscular benadryl and steroids. No respiratory, gastrointestinal, oral, or neurologic symptoms were noted, and the patient was discharged to home and prescribed five days of oral steroids. After four days, the patient's symptoms were "less", but not completely resolved. A corrective version was created using the original receipt date for the sole purpose of entering the suspect product Typhim per standard data entry procedure. No other medically significant information was received.
Age: 36.0
Sex: F
Vaccine: JEV, RAB, TYP, JEV, RAB
Symptoms: Joint swelling, Urticaria generalised
Clinical narrative: SEROUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. A 36-year-old female patient with no known medical history had received a subcutaneous right arm injection of JE-Vax (lot number EJN236A, a left arm injection of Typhim (lot number Z0479), and a intramuscular left arm injection of Rabavert (lot number 412011A). On 07 May 2007 the patient received a dose of Typhim (she had received "one or two" previous doses). On 22 May 2007, she received her third dose of JE-Vax and first dose of Rabavert. On 29 May 2007 the patient received her fourth dose of JE-Vax and second dose of Rabavert. Approximately 72 hours later, on 01 June 2007, she developed acute generalized severe urticaria in addition to small and large joint swelling. The patient presented to the emergency department and was treated with intramuscular benadryl and steroids. No respiratory, gastrointestinal, oral, or neurologic symptoms were noted, and the patient was discharged to home and prescribed five days of oral steroids. After four days, the patient's symptoms were "less", but not completely resolved. A corrective version was created using the original receipt date for the sole purpose of entering the suspect product Typhim per standard data entry procedure. No other medically significant information was received.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Adacel vaccine given (L) deltoid caused persistent pain distal (3") to site
Sex: F
Vaccine: HEP
Symptoms: Injection site induration, Injection site reaction
Clinical narrative: Area around injection sites of Engerix-B are hard and have small circles when medication was injected.
Sex: M
Vaccine: HEP
Symptoms: Injection site pruritus, Pruritus, Rash, Skin disorder
Clinical narrative: Heptavax (Engerix B) given in R and L deltoids IM. On 5/31/2007 patient reported bilateral rash and pruritus. No discoloration observed on patient's dark skin but several raised areas palpated bilaterally. Reports intermittent itching at both sites diminishing today.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Haematochezia
Clinical narrative: Baby had blood in diaper following bowel movement.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Hyperhidrosis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right arm at vaccine sit, red, swollen, hot. Patient has chills and hot sweats.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Rash
Clinical narrative: Developed rash 8 days after receiving MMR.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Gardasil vaccine administered without difficulty or reaction. RN notified that patient is pregnant approximately 10 weeks. Patient would have been 3 3/7 weeks at administration.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Full blood count, Infection, Laboratory test normal, Lymphadenopathy, Mononucleosis heterophile test negative
Clinical narrative: 1-16-07 _> 1st Gardasil + Hep A administered 1-29-07 Infected lymph nodes in neck w/fever Amoxicillin for 10 days. 4-4-07-2nd Gardasil shot only 5-18-07-Infected lymph nodes in neck with fever Amoxicillin-10 days-didnt work-Ceftin 1000
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Pyrexia, Vaccine positive rechallenge
Clinical narrative: 1-16-07 _> 1st Gardasil + Hep A administered 1-29-07 Infected lymph nodes in neck w/fever Amoxicillin for 10 days. 4-4-07-2nd Gardasil shot only 5-18-07-Infected lymph nodes in neck with fever Amoxicillin-10 days-didnt work-Ceftin 1000
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Culture throat negative, Lymphadenitis, Lymphadenopathy, Lymphadenopathy, Pharyngolaryngeal pain
Clinical narrative: 1-16-07 _> 1st Gardasil + Hep A administered 1-29-07 Infected lymph nodes in neck w/fever Amoxicillin for 10 days. 4-4-07-2nd Gardasil shot only 5-18-07-Infected lymph nodes in neck with fever Amoxicillin-10 days-didnt work-Ceftin 1000
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, IPV, MMR, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: IPV was given and Pediarix was accidentally given in place of DTaP, patient received 2 doses of IPV, contacted manufacturer and they stated no reason for concern, notified doctor of incident.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, IPV
Symptoms: Wrong drug administered
Clinical narrative: IPV was given and Pediarix was accidentally given in place of DTaP, patient received 2 doses of IPV, contacted manufacturer and they stated no reason for concern, notified doctor of incident.
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site warmth, Skin lesion
Clinical narrative: 3cm indurated erythematous warm circular lesion at site of vaccination.
Age: 0.22
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: MMR was administered to this child at age of three months. (MMR- Lot# 0497F)
Age: 11.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Induration, Oedema peripheral
Clinical narrative: 1.5 - 2" Round, swelling, red, induration at triceps area. Varivax
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Cellulitis
Clinical narrative: Cellulitis left upper arm. Rx: Co-trimoxazole suspension 2 tsp BID x 10 days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema
Clinical narrative: Redness on left thigh, antibiotic
Age: 17.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Blood pressure, Grand mal convulsion
Clinical narrative: Approximately 4 to 5 minutes after administered of vaccines. Patient experienced tonic/clonic seizure. Patient recovered immediately v/s stable transported to E.D.
Age: 38.0
Sex: F
Vaccine: TD
Symptoms: Injection site haematoma, Injection site swelling
Clinical narrative: Swelling at site of injection. Firm 1/2 x 1cm feels like hematoma.
Age: 35.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Arthralgia, Fatigue, Headache, Pyrexia
Clinical narrative: Severe and persistent joint pain and fatigue.  Severe joint pain started approx. 8 hours after 1st vaccination on 3-27-07.  Joint pain did not subside.  Increased on 4-9-07 at second vaccination.  Third vaccination on 5-26-07 has resulted in persistent and severe joint pain and fatigue that I am still dealing with presently.  Currently dealing with severe joint pain that is not affected with Naproxen, Tramadol, Flexeril, or Vicodin.  Headaches have subsided recently.  Have recorded a fever as high as 101.  Dealing with severe fatigue.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC
Symptoms: Pyrexia, Rash macular
Clinical narrative: reported cl woke up 6/10/07 a.m. with large blotches everywhere and low grade fever.  Went to urgent care - reports probable reaction to MMRV, benadryl ordered - continues to fade and get new blotches as of 6/12/07 and low grade fever
Age: 34.0
Sex: M
Vaccine: SMALL
Symptoms: Rash generalised
Clinical narrative: Rash developed rash all over body after receiving the Smallpox vaccination.  Pt dx with Vaccina. Pt treated with Keflex 500mg and Zyrtec 10 mg and instructed to return to clinic if condition persists or worsens.
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Local reaction, Skin warm, Swelling
Clinical narrative: Large local reaction - 5x3cm erythematous, warm, non tender, swollen
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Feeling cold, Injection site discomfort, Injection site pain, Musculoskeletal stiffness
Clinical narrative: I received Adacel in my left arm on a Thursday.  On Saturday I noticed a mild pain in my left axilla.  By Monday afternoon, I had a dull ache in my entire left arm into my hand.  My left arm felt heavy and cold.  My fingers felt stiff.  I had pins and needles off and on in my entire arm.  I started using anti-inflammatories with improvement in symptoms.  The symptoms have not completely resolved yet.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: I received Adacel in my left arm on a Thursday.  On Saturday I noticed a mild pain in my left axilla.  By Monday afternoon, I had a dull ache in my entire left arm into my hand.  My left arm felt heavy and cold.  My fingers felt stiff.  I had pins and needles off and on in my entire arm.  I started using anti-inflammatories with improvement in symptoms.  The symptoms have not completely resolved yet.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain, swelling, redness at injection site. area firm and warm to touch. Patient states that the pain radiated into her neck and under her arm.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Pain, swelling, redness at injection site. area firm and warm to touch. Patient states that the pain radiated into her neck and under her arm.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Blood lead, Haemoglobin, Injection site erythema, Injection site urticaria
Clinical narrative: Noted wheal like blanching below injection site,  area around injection site turned bright red
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Injection site swelling, Tenderness
Clinical narrative: R arm upper arm swelling around injection site. Area of induration, erythema, slightly tender.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood lead, Haemoglobin, Injection site erythema, Injection site urticaria
Clinical narrative: Noted wheal like blanching below injection site on right thigh; area around injection site turned bright red; benedryl given per Provider request