chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Inflammation
Clinical narrative: Information has been received from a pharmacist concerning a female who on 03-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck) "one dose" (Route and Lot # not reported). On 11-APR-2008 the patient developed a rash all over her arm (specific arm unspecified) after receiving zoster vaccine live (Oka/Merck). The patient sought unspecified medical attention. Additional information has been requested. Follow-up received 10/08/2008 reported patient with diabetes, hypertension, and hypercholesterolaemia was vaccinated with a first dose of zoster vacciine live in the left posterolateral arm. Concomitant therapy included ACCURETIC and GLUCOTROL. There was no illness at time of vaccination. On 11-APR-2009 the patient was seen in the office and presented with 20 cm diameter erythematous area. Hydrocortizone was recommended and used by the patient. On 23-APR-2008 inflammation area had extended from elbow to shoulder. The patient was treated with DIPROLENE cream and oral ZYRTEC. At the time of report, the outcome was unknown. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dermatitis, Erythema, Rash
Clinical narrative: Information has been received from a pharmacist concerning a female who on 03-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck) "one dose" (Route and Lot # not reported). On 11-APR-2008 the patient developed a rash all over her arm (specific arm unspecified) after receiving zoster vaccine live (Oka/Merck). The patient sought unspecified medical attention. Additional information has been requested. Follow-up received 10/08/2008 reported patient with diabetes, hypertension, and hypercholesterolaemia was vaccinated with a first dose of zoster vacciine live in the left posterolateral arm. Concomitant therapy included ACCURETIC and GLUCOTROL. There was no illness at time of vaccination. On 11-APR-2009 the patient was seen in the office and presented with 20 cm diameter erythematous area. Hydrocortizone was recommended and used by the patient. On 23-APR-2008 inflammation area had extended from elbow to shoulder. The patient was treated with DIPROLENE cream and oral ZYRTEC. At the time of report, the outcome was unknown. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 64 year old female consumer with no known allergies, hypothyroidism, mitral valve prolapse, osteoporosis and a history of chickenpox as a child who on 26-APR-2008 was vaccinated SQ in the left arm with 0.65ml of with ZOSTAVAX (Oka/Merck) (lot # 659760/0159X).  Concomitant therapy included SYNTHROID, MOBIC, alendronate sodium (MSD) and TOPROL XL TABLETS.  Subsequently, the evening of the vaccination the patient developed swelling at the injection site.  The next morning on 27-APR-2008 the patient noticed a rash at the injection site.  A neighbor who is a nurse said the rash was a sun blister type and looked like a varicella rash around the injection site of the left arm.  The area was not painful unless the patient pressed against it.  There was mild itching to the area.  Medical attention was sought by a phone call.  There were no lab studies performed.  At the time of the report the patient had not recovered.  It was noted that the physician was on her way to the office to see the patient.  There was no product quality complaint involved.  Follow-up information from the physician indicated that she examined the patient.  No further information was provided.  Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Injection site vesicles, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 64 year old female consumer with no known allergies, hypothyroidism, mitral valve prolapse, osteoporosis and a history of chickenpox as a child who on 26-APR-2008 was vaccinated SQ in the left arm with 0.65ml of with ZOSTAVAX (Oka/Merck) (lot # 659760/0159X).  Concomitant therapy included SYNTHROID, MOBIC, alendronate sodium (MSD) and TOPROL XL TABLETS.  Subsequently, the evening of the vaccination the patient developed swelling at the injection site.  The next morning on 27-APR-2008 the patient noticed a rash at the injection site.  A neighbor who is a nurse said the rash was a sun blister type and looked like a varicella rash around the injection site of the left arm.  The area was not painful unless the patient pressed against it.  There was mild itching to the area.  Medical attention was sought by a phone call.  There were no lab studies performed.  At the time of the report the patient had not recovered.  It was noted that the physician was on her way to the office to see the patient.  There was no product quality complaint involved.  Follow-up information from the physician indicated that she examined the patient.  No further information was provided.  Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacist concerning a 76 year old female patient with no pre-existing medical conditions, birth defects, or allergies who on 22-APR-2008 at 4:40 PM was vaccinated SC in the left arm with a first dose of zoster vaccine live (Oka/Merck) (Lot# 659760/0159X). On 23-APR-2008, at noon the patient experienced a rash. The rash lasted for approximately 6 days and started to clear on 30-APR-2008. At the time of this report, the patient had recovered. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a health professional concerning a 79 year old female with a penicillin allergy who on 23-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck) subcutaneously in the left arm (Lot #659760/0159X). On 25-APR-2008, the patient developed a rash around the injection site. The rash lasted for two days, and then the patient recovered. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated in the pharmacy with zoster vaccine live (Oka/Merck) 0.5 mL SQ. The patient experienced immediate injection site redness/erythema, injection site swelling, and injection site pain. The "reaction" continued down the patient's arm. Subsequently, the patient recovered. Additional information has been requested. Additional information was received from the pharmacist and reported that the patient returned for follow up at the pharmacy and will also need additional follow up. The physician was concerned that the pharmacist used the wrong administration technique, but no further details were reported. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008.  Information has been received from a pharmacist concerning a 69 year old female, weight 140lb, who on an 02-MAY-2008 was vaccinated in the pharmacy with ZOSTAVAX (Merck) 0.5 ml SQ.  Subsequently the patient experienced immediate injection site redness/erythema.  Injection site swelling, and injection site pain.  The "reaction" continued down the patient's arm.  Subsequently, the patient recovered.  Additional information has been requested.  Additional information was received from the pharmacist and reported that the patient returned for follow up at the pharmacy and will also need additional follow up.  The physician was concerned that the pharmacist used the wrong administration technique, but no further details were reported.  Follow up information received from a nurse practitioner reported that the patient's redness and swelling at the injection site were "more than expected".  The patient was treated with warm  compressand KEFLEX 250mg twice a day for 7 days.  The reporter considered  redness and swelling at injection site to be an other important medical event.  Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling, Wrong technique in drug usage process
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated in the pharmacy with zoster vaccine live (Oka/Merck) 0.5 mL SQ. The patient experienced immediate injection site redness/erythema, injection site swelling, and injection site pain. The "reaction" continued down the patient's arm. Subsequently, the patient recovered. Additional information has been requested. Additional information was received from the pharmacist and reported that the patient returned for follow up at the pharmacy and will also need additional follow up. The physician was concerned that the pharmacist used the wrong administration technique, but no further details were reported. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008.  Information has been received from a pharmacist concerning a 69 year old female, weight 140lb, who on an 02-MAY-2008 was vaccinated in the pharmacy with ZOSTAVAX (Merck) 0.5 ml SQ.  Subsequently the patient experienced immediate injection site redness/erythema.  Injection site swelling, and injection site pain.  The "reaction" continued down the patient's arm.  Subsequently, the patient recovered.  Additional information has been requested.  Additional information was received from the pharmacist and reported that the patient returned for follow up at the pharmacy and will also need additional follow up.  The physician was concerned that the pharmacist used the wrong administration technique, but no further details were reported.  Follow up information received from a nurse practitioner reported that the patient's redness and swelling at the injection site were "more than expected".  The patient was treated with warm  compressand KEFLEX 250mg twice a day for 7 days.  The reporter considered  redness and swelling at injection site to be an other important medical event.  Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site induration, Injection site rash, Injection site reaction
Clinical narrative: Information has been received from a PharmD concerning a 69-year-old female who on 06-MAY-2008 was vaccinated subcutaneous in the right arm with a 0.65 mL dose of zoster vaccine live (Oka/Merck) (lot # 659268/0158X). On approximately 06-MAY-2008, post vaccination, the patient developed a two inch round raised circular area at the injection site. The patient sought medical attention via a phone call. The patient reported she went to see her physician and she was told to take BENADRYL. The patient said she was not concerned about the reaction. She found it inadvertently while putting on deodorant and it does not bother her (was not noticeable to her or painful). A product quality complaint was not involved. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a PharmD concerning a 69-year-old female who on 06-MAY-2008 was vaccinated subcutaneous in the right arm with a 0.65 mL dose of zoster vaccine live (Oka/Merck) (lot # 659268/0158X). On approximately 06-MAY-2008, post vaccination, the patient developed a two inch round raised circular area at the injection site. The patient sought medical attention via a phone call. The patient reported she went to see her physician and she was told to take BENADRYL. The patient said she was not concerned about the reaction. She found it inadvertently while putting on deodorant and it does not bother her (was not noticeable to her or painful). A product quality complaint was not involved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Lip swelling, Oedema peripheral, Swelling face, Vaccine positive rechallenge
Clinical narrative: Information has been received from a consumer concerning her 19 year old daughter who is "allergic to sulfa" and on 02-JAN-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot # not reported). On 05-MAR-2008 her daughter was vaccinated intramuscularly with a 0.5 mL second dose of GARDASIL vaccine (yeast) (lot # not reported). There was no concomitant medication. The consumer reported that "her daughter experienced swelling after getting the first shot. First her lips swelled up, then her face and then her arms. The swelling usually lasts about 10 hours". The consumer also reported that after the second vaccination, administered on 05-MAR-2008, her daughter developed "sporadic white bumps" on her arms. It was also reported that "after the first time she experienced swelling, she experienced swelling on 21-FEB-2008, 22-FEB-2008, 20-MAR-2008, 26-MAR-2008, 01-APR-2008, 08-APR-2008, 10-APR-2008, 26-APR-2008, 27-APR-2008, 26-MAY-2008, 27-MAY-2008 and 30-MAY-2008. She did not have records of every date she experienced swelling. She is presently not experiencing any swelling. She will not be completing the series. The daughter sought unspecified medical attention. The consumer reported that her daughter's swelling improved after stopping therapy.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Lip swelling, Oedema peripheral, Rash papular, Swelling face
Clinical narrative: Information has been received from a consumer concerning her 19 year old daughter who is "allergic to sulfa" and on 02-JAN-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot # not reported). On 05-MAR-2008 her daughter was vaccinated intramuscularly with a 0.5 mL second dose of GARDASIL vaccine (yeast) (lot # not reported). There was no concomitant medication. The consumer reported that "her daughter experienced swelling after getting the first shot. First her lips swelled up, then her face and then her arms. The swelling usually lasts about 10 hours". The consumer also reported that after the second vaccination, administered on 05-MAR-2008, her daughter developed "sporadic white bumps" on her arms. It was also reported that "after the first time she experienced swelling, she experienced swelling on 21-FEB-2008, 22-FEB-2008, 20-MAR-2008, 26-MAR-2008, 01-APR-2008, 08-APR-2008, 10-APR-2008, 26-APR-2008, 27-APR-2008, 26-MAY-2008, 27-MAY-2008 and 30-MAY-2008. She did not have records of every date she experienced swelling. She is presently not experiencing any swelling. She will not be completing the series. The daughter sought unspecified medical attention. The consumer reported that her daughter's swelling improved after stopping therapy.
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, FLU3, HEPA, MMRV
Symptoms: Erythema, Rash, Rash papular
Clinical narrative: Information has been received from a medical assistant concerning a 17 month old male with no pertinent medical history or drug allergies who on 03-OCT-2007 was vaccinated SC with a 0.5 ml dose of PROQUAD (lot# 657270/0911U).  Concomitant vaccinations administered on that same day included a dose of VAQTA (inactive) (manufacturer unknown) and a dose of Influenza virus vaccine (unspecified).  The patient developed shingles consisting of approximately 20 lesions on each area of his left upper arm, left upper back and chest "6 months after vaccination."  The patient was seen by the physician for medical attention.  No labs or diagnostic studies were performed.  The patient was not recovered at the time of this report.  No further information is available.  There was no product quality complaint.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/3/2008. Follow-up information from a physician indicated that the 18 month old male who on 03-OCT-2007 was vaccinated SC with his first dose of PROQUAD (Merck) (lot# 675270/0911U) in the anterolateral left arm. There was no illness at the time of vaccination. Concomitant vaccinations administration on that same day included the first dose of HAVRIX (lot# AHAVB181AA) in the left deltoid and the first dose of FLUZONE (lot# UT2474CA). On 23-APR-2008 the patient experienced shingles characterized by T2-T3 dermatomal distribution of clustered papules on the left back arm and left upper back immediately adjacent to the arm rash. No labs or diagnostic studies were performed. On 14-MAY-2008 the patient recovered from shingles. Additional follow-up information from a physician in the same office indicated that the 18 month old male with on history of chickenpox or recent exposure to chickenpox or herpes zoster and an onset of rash which began on 19-APR-2008 with approximately 20 clustered red papules on the left lateral back at T2 & T3 and 20 clustered papules on the left lateral back arm. The rash did not occur at the injection site and was not within 42 days after vaccination. The patient did not have a temperature and pain 1 out of 10. No direct fluorescent antibody, PCK specimen collection or photo noted. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, FLU3, HEPA, MMRV
Symptoms: Herpes zoster, Rash, Rash papular, Skin lesion
Clinical narrative: Information has been received from a medical assistant concerning a 17 month old male with no pertinent medical history or drug allergies who on 03-OCT-2007 was vaccinated SC with a 0.5 ml dose of PROQUAD (lot# 657270/0911U).  Concomitant vaccinations administered on that same day included a dose of VAQTA (inactive) (manufacturer unknown) and a dose of Influenza virus vaccine (unspecified).  The patient developed shingles consisting of approximately 20 lesions on each area of his left upper arm, left upper back and chest "6 months after vaccination."  The patient was seen by the physician for medical attention.  No labs or diagnostic studies were performed.  The patient was not recovered at the time of this report.  No further information is available.  There was no product quality complaint.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/3/2008. Follow-up information from a physician indicated that the 18 month old male who on 03-OCT-2007 was vaccinated SC with his first dose of PROQUAD (Merck) (lot# 675270/0911U) in the anterolateral left arm. There was no illness at the time of vaccination. Concomitant vaccinations administration on that same day included the first dose of HAVRIX (lot# AHAVB181AA) in the left deltoid and the first dose of FLUZONE (lot# UT2474CA). On 23-APR-2008 the patient experienced shingles characterized by T2-T3 dermatomal distribution of clustered papules on the left back arm and left upper back immediately adjacent to the arm rash. No labs or diagnostic studies were performed. On 14-MAY-2008 the patient recovered from shingles. Additional follow-up information from a physician in the same office indicated that the 18 month old male with on history of chickenpox or recent exposure to chickenpox or herpes zoster and an onset of rash which began on 19-APR-2008 with approximately 20 clustered red papules on the left lateral back at T2 & T3 and 20 clustered papules on the left lateral back arm. The rash did not occur at the injection site and was not within 42 days after vaccination. The patient did not have a temperature and pain 1 out of 10. No direct fluorescent antibody, PCK specimen collection or photo noted. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a 61 year old female patient with a penicillin allergy and no pertinent medical history who on 14-MAY-2008 was vaccinated SC with a 0.65 mL dose of zoster vaccine live (Oka/Merck) at a pharmacy. There was no concomitant medication. Her injection site area was red and sore on the same day of the vaccination. The next day, there was a 6 inch diameter swollen area on the injection site. She was seen by a physician and he diagnosed cellulitis. The physician prescribed 500 mg CIPRO BID for 7 days. As of 21-MAY-2008, her symptoms were resolving. No diagnostic tests were performed. No further information was provided. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008. Follow-up information was received from a registered nurse which reported that the 61 year old female patient with a penicillin allergy and medical history of rash who on 14-MAY-2008 was vaccinated SC with a first 0.65 mL dose of ZOSTAVAX (Merck) (lot # 659326/1824U) in the left upper arm at approximately 1700. The patient developed pain, burning, swollen, and hot. CIPRO, 500mg, BID for 7 days was prescribed for cellulitis. The patient denied fever. There was no known illness at the time of vaccination. At the time of this report, the patient recovered. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin warm
Clinical narrative: Information has been received from a nurse practitioner concerning a 61 year old female patient with a penicillin allergy and no pertinent medical history who on 14-MAY-2008 was vaccinated SC with a 0.65 mL dose of zoster vaccine live (Oka/Merck) at a pharmacy. There was no concomitant medication. Her injection site area was red and sore on the same day of the vaccination. The next day, there was a 6 inch diameter swollen area on the injection site. She was seen by a physician and he diagnosed cellulitis. The physician prescribed 500 mg CIPRO BID for 7 days. As of 21-MAY-2008, her symptoms were resolving. No diagnostic tests were performed. No further information was provided. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008. Follow-up information was received from a registered nurse which reported that the 61 year old female patient with a penicillin allergy and medical history of rash who on 14-MAY-2008 was vaccinated SC with a first 0.65 mL dose of ZOSTAVAX (Merck) (lot # 659326/1824U) in the left upper arm at approximately 1700. The patient developed pain, burning, swollen, and hot. CIPRO, 500mg, BID for 7 days was prescribed for cellulitis. The patient denied fever. There was no known illness at the time of vaccination. At the time of this report, the patient recovered. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a 61 year old female patient with a penicillin allergy and no pertinent medical history who on 14-MAY-2008 was vaccinated SC with a 0.65 mL dose of zoster vaccine live (Oka/Merck) at a pharmacy. There was no concomitant medication. Her injection site area was red and sore on the same day of the vaccination. The next day, there was a 6 inch diameter swollen area on the injection site. She was seen by a physician and he diagnosed cellulitis. The physician prescribed 500 mg CIPRO BID for 7 days. As of 21-MAY-2008, her symptoms were resolving. No diagnostic tests were performed. No further information was provided. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008. Follow-up information was received from a registered nurse which reported that the 61 year old female patient with a penicillin allergy and medical history of rash who on 14-MAY-2008 was vaccinated SC with a first 0.65 mL dose of ZOSTAVAX (Merck) (lot # 659326/1824U) in the left upper arm at approximately 1700. The patient developed pain, burning, swollen, and hot. CIPRO, 500mg, BID for 7 days was prescribed for cellulitis. The patient denied fever. There was no known illness at the time of vaccination. At the time of this report, the patient recovered. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Skin warm, Swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a 61 year old female patient with a penicillin allergy and no pertinent medical history who on 14-MAY-2008 was vaccinated SC with a 0.65 mL dose of zoster vaccine live (Oka/Merck) at a pharmacy. There was no concomitant medication. Her injection site area was red and sore on the same day of the vaccination. The next day, there was a 6 inch diameter swollen area on the injection site. She was seen by a physician and he diagnosed cellulitis. The physician prescribed 500 mg CIPRO BID for 7 days. As of 21-MAY-2008, her symptoms were resolving. No diagnostic tests were performed. No further information was provided. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008. Follow-up information was received from a registered nurse which reported that the 61 year old female patient with a penicillin allergy and medical history of rash who on 14-MAY-2008 was vaccinated SC with a first 0.65 mL dose of ZOSTAVAX (Merck) (lot # 659326/1824U) in the left upper arm at approximately 1700. The patient developed pain, burning, swollen, and hot. CIPRO, 500mg, BID for 7 days was prescribed for cellulitis. The patient denied fever. There was no known illness at the time of vaccination. At the time of this report, the patient recovered. Additional information is not expected.
Age: 0.42
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Unresponsive to stimuli
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 5-month-old patient who experienced passed away.  The patient received a dose on 01-Jul-2008.  The patient also received a dose of PEDIARIX (GlaxoSmithKline), a dose of ROTATEQ (Merck & Co Inc) and a dose of ACT-HIB (Aventis) on 01-Jul-2008.  Relevant medical history was not provided.  Concomitant medications were not reported.  On 01-Jul-2008 the patient was vaccinated with PREVNAR, PEDIARIX, ACT-HIB and ROTATEQ.  The patient passed away later that evening.  It was unknown if the child expired at home or was hospitalized.  The cause of death was reported as unknown.  No additional information was available at the time of this report.
Age: 0.42
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Death
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 5-month-old patient who experienced passed away.  The patient received a dose on 01-Jul-2008.  The patient also received a dose of PEDIARIX (GlaxoSmithKline), a dose of ROTATEQ (Merck & Co Inc) and a dose of ACT-HIB (Aventis) on 01-Jul-2008.  Relevant medical history was not provided.  Concomitant medications were not reported.  On 01-Jul-2008 the patient was vaccinated with PREVNAR, PEDIARIX, ACT-HIB and ROTATEQ.  The patient passed away later that evening.  It was unknown if the child expired at home or was hospitalized.  The cause of death was reported as unknown.  No additional information was available at the time of this report.
Age: 0.42
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Death, Respiratory arrest
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 5-month-old patient who experienced passed away.  The patient received a dose on 01-Jul-2008.  The patient also received a dose of PEDIARIX (GlaxoSmithKline), a dose of ROTATEQ (Merck & Co Inc) and a dose of ACT-HIB (Aventis) on 01-Jul-2008.  Relevant medical history was not provided.  Concomitant medications were not reported.  On 01-Jul-2008 the patient was vaccinated with PREVNAR, PEDIARIX, ACT-HIB and ROTATEQ.  The patient passed away later that evening.  It was unknown if the child expired at home or was hospitalized.  The cause of death was reported as unknown.  No additional information was available at the time of this report.
Age: 0.3
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Autopsy, Death
Clinical narrative: Information has been received from an office worker concerning a 4 month old patient who was vaccinated with oral ROTATEQ (lot # 660548/0501X), (therapy date and dose not reported).  The baby died the same day ROTATEQ was given to the patient.  Per office worker, they had a memo in their office not to give any further vaccines to patients because one 4 month old baby died after receiving ROTATEQ.  The office is currently waiting for the autopsy report before they can resume giving vaccines in their office.  Per office worker, the patient is not a patient in their office.  The Director of Pharmacy from the pharmacy who dispensed ROTATEQ provided the name of the patient's physician and lot # 0501X.  Additional information was received from a pharmacist, indicating that this patient also received second dose of ACTHIB, PREVNAR and PEDIARIX on the same day that a second dose of ROTATEQ was given.  It was reported that the patient sought unspecified medical attention, physician.  The event was considered life threatening and disabling.  A lot check has been requested.  Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Inappropriate schedule of drug administration, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received through the Merck pregnancy registry from a nurse concerning a 29 year old female consumer with hepatitis b positive and pineapple allergy who on 24-MAR-2008 was vaccinated SQ with one dose of 0.5ml of VARIVAX (Oka/Merck) (lot # 659607/1760U).  Suspect vaccination included MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3).  Concomitant vaccination included DTaP.  The nurse reported that the patient is now pregnant.  The patient's LMP was reported as 18-FEB-2008.  Medical attention was sought, the patient called the office.  A urine pregnancy test confirmed the pregnancy.  No symptoms were reported.  It was noted that the patient was to schedule an appointment with the physician.  At the time of the report the outcome of the pregnancy was unknown.  There was no product quality complaint involved.  Additional information has been requested.  Additional information has been received which reported that the patient had a spontaneous abortion on 09-Apr-2008 (7 weeks from the patient's LMP).  The lot number for DTaP was reported as PMCC02775AA.  It was reported that no other medications were used during this pregnancy.  Upon internal review, it was determined that spontaneous abortion was an other important medical event.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 10 year old male student with rhinitis allergic who on 16-APR-1999 and 03-JUN-2008 was vaccinated subcutaneously with first and second doses, respectively. of VARIVAX (Oka/Merck) (Lot # of second dose 659357/1567U).  Concomitant therapy included FLONASE, ALLEGRA and BENADRYL.  On 04-JUN-2008 the patient developed swelling and tenderness.  On 05-JUN-2008 the patient developed redness with swelling.  The area was outlined in pen.  On 06-JUN-2008 the patient's swelling and redness extended outside circled area.  The patient was treated with cephalexin, 250 mg/ 5 ml, 2 tsp every 12 hours for 10 days.  At the time of the report, the patient had not recovered from the events.  The reporter considered swelling, tenderness and redness to be important medical events.  This is one of several reports from the same source.  Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: FLU3, HEPAB, MMR, MNQ, TDAP, VARCEL
Symptoms: Injection site papule, Injection site rash, Rash, Tonsillitis
Clinical narrative: The Patient is a 23 year old female.  She reported: Encounter Background Information: pt was discharged from the medical center today.  Pt was in-patient at the medical center bec of possible varicella after the chicken pox vaccination 3-4 wks ago. Pt was told that it could just be a allergic reaction to the varicella shot.  Pt. stayed in the hospital for 5 days.  The skin lesions are all gone at this time.  No other c/o.  Skin symptoms skin rashes are all healed.  7/11/08 Case will be closed w/medical records that accompanied report. Hospitalized 6/1-6/4/2008.  FINAL DX: Allergic reaction to varicella vaccination. Records reveal patient received varicella vaccine due to negative serology for VZV & experienced erythematous rash at injection site next day.  Then experienced neck stiffness & pain, LUE swelling, rash, sore throat, HA approx 4 wks s/p vaccinations.  Started on oral antibiotics for LUE infection day before.  Exam 5/30/08 revealed revealed tonsillar enlargement, LUE swollen, tender, erythema w/diffuse papular lesion over face, scalp, arms & trunk.  Admitted to hospital for observation for possible varicella post vaccine.  ID consult done & felt was allergic reaction, not chickenpox.  No complications & most lesions healed by d/c to home.
Age: 4.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Child brought to clinic to receive his kindergarten immunizations. Instead of receiving his fifth dose of DTaP he received TdaP, which is for children over 11 years of age. No adverse reaction seen at the time of immunization and nothing occurred or was reported to the clinic. Attempted to contact mother on 06/27/08 for status of child but the number mom provided was wrong.
Age: 0.2
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Irritability, Kawasaki's disease, Lethargy, Pyrexia
Clinical narrative: Information has been received from a case in litigation from information obtained from a published literature article concerning an 8 week old female who in September 2002, when she was 2 days old, was vaccinated with a first dose of RECOMBIVAX HB (manufacturer unknown).  On 14-NOV-2002, the patient was vaccinated with a second dose of RECOMBIVAX HB (manufacturer unknown).  On approximately 14-NOV-2002, "within hours," the patient developed a low grade fever, became lethargic and developed a rash.  Within 24 hours she developed vomiting, diarrhea and became fussy.  On 07-DEC-2002, she was diagnosed with Kawasaki disease.  At the time of the report, the patient's outcome was unknown.  Upon internal review, Kawasaki disease was considered to be an other important medical event.  The reporter felt that Kawasaki disease was caused by RECOMBIVAX HB.  No further information is available.
Age: 0.2
Sex: F
Vaccine: HEP
Symptoms: Rash, Vomiting
Clinical narrative: Information has been received from a case in litigation from information obtained from a published literature article concerning an 8 week old female who in September 2002, when she was 2 days old, was vaccinated with a first dose of RECOMBIVAX HB (manufacturer unknown).  On 14-NOV-2002, the patient was vaccinated with a second dose of RECOMBIVAX HB (manufacturer unknown).  On approximately 14-NOV-2002, "within hours," the patient developed a low grade fever, became lethargic and developed a rash.  Within 24 hours she developed vomiting, diarrhea and became fussy.  On 07-DEC-2002, she was diagnosed with Kawasaki disease.  At the time of the report, the patient's outcome was unknown.  Upon internal review, Kawasaki disease was considered to be an other important medical event.  The reporter felt that Kawasaki disease was caused by RECOMBIVAX HB.  No further information is available.
Age: 1.59
Sex: M
Vaccine: HEPA, MM, PNC, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Child in clinic to receive 1 yr shots. Instead of 4th dose of DTaP, the child received TdaP. No adverse reaction noted, none reported to clinic. Attempt to contact mother for follow up but wrong phone number was provided by the mother.   No adverse event reported.
Age: 0.2
Sex: F
Vaccine: RV5, UNK
Symptoms: Petechiae, Platelet count decreased, Rash generalised
Clinical narrative: Information has been received from a physician concerning a 2 month old female infant who on an unspecified date was vaccinated orally with ROTATEQ. Concomitant vaccinations included "normal vaccinations for 2 month visit." Subsequently, after receiving ROTATEQ along with other "normal vaccines" the infant developed "petechiae" (rash) which covered her entire body. The physician took a blood test in the office that revealed low platelets. The patient was admitted to the hospital that same evening and another blood test was done that revealed the patient's platelets were normal. At the time of the report the patient recovered on an unspecified date. There was no product quality complaint involved. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Drug exposure during pregnancy, Prolonged labour, Ultrasound scan normal
Clinical narrative: Initial and follow up information has been received from a physicians assistant through the Merck pregnancy registry concerning herself, a 26 year old female with no known allergies and no pertinent medical history who on 07-JUN-2007 was vaccinated with GARDASIL (Lot # 0212U) and discovered she was pregnant on 28-JUL-2007 (LMP 08-JUL-2007). Concomitant therapy included a prenatal vitamin. The patient sought medical attention (office visit). No labs or diagnostic studies were performed. On 02-OCT-2007, the patient reported she was twelve weeks pregnant, felt fine and had no adverse symptoms. On 05-DEC-2007 the patient underwent a routine ultrasound indicated for the pregnancy and the result was negative. The patient reported that on 10-APR-2008 she underwent a cesarean section due to delayed cervical dilation during labor. She delivered a normal male infant weighing: 6lbs 13ozs; length: 19". The patient reported that both mother and baby were doing fine. Upon internal review, the patient's cesarean section due to delayed cervical dilation was considered to be an other important medical event. Additional information is not expected.
Age: 19.0
Sex: U
Vaccine: ANTH, SMALL
Symptoms: Computerised tomogram abnormal, Face oedema, Hypoaesthesia facial, Lymphadenopathy, Mass
Clinical narrative: Swelling, pain and numbness of lt jaw beginning 3 ds post spv. Sxs began with tingling and numbness in left face and the next day lt side of face was swollen. Now has palpable "lump" on lt face. SPV given on lt deltoid. Had axillary LAD. but no cervical LAD. Attempt made to drain lesion but no fluid obtained. Low grade fever, which was now resolved.
Age: 19.0
Sex: U
Vaccine: ANTH, SMALL
Symptoms: Pain in jaw, Paraesthesia, Pyrexia, Swelling face
Clinical narrative: Swelling, pain and numbness of lt jaw beginning 3 ds post spv. Sxs began with tingling and numbness in left face and the next day lt side of face was swollen. Now has palpable "lump" on lt face. SPV given on lt deltoid. Had axillary LAD. but no cervical LAD. Attempt made to drain lesion but no fluid obtained. Low grade fever, which was now resolved.
Age: 69.0
Sex: M
Vaccine: YF
Symptoms: Asthenia, Confusional state, Myasthenia gravis, Nervous system disorder, Pyrexia
Clinical narrative: Pt with a pertinent medical history of myasthenia gravis which was being treated with 25 mg of prednisone every other day.  Received YF vax on  5/9/2008, and on 5/13/08 developed fevers of 102F to 103F that persisted for three days.  On 5/17/08 the patient defervesced, but became febrile on 5/20/08 (again 102F to 103F).   The patient developed confusion on 5/22/08 and was admitted to hospital on 5/23. This is a case of suspected YF vax assocated neurotropic disease. CSF and serum samples were sent to CDC lab for Yellow fever testing. 7/28/08-records received for DOS 5/22-5/28/08-DC DX: Post yellow fever vaccine encephalitis. Fever, resolved. On admission temperature of 101.8. Received yellow fever vaccination while chronically immunosuppressed. Decreased strength weakness of lower extremities. Fell, confused, diarrhea and decreased appetite. Follow-up Information 12-SEP-2008: Encephalitis due to YF vaccine
Age: 1.3
Sex: M
Vaccine: DTAPH, HEPA
Symptoms: Oedema peripheral
Clinical narrative: He had marked swelling of both lower extremity that improved with motrin.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying
Clinical narrative: 50 hours after vaccination had 8-9 hours of inconsolable crying. Reviewed by phone after 9 hours (2100), given tylenol, had normal exam the following morning.
Age: 36.0
Sex: M
Vaccine: TTOX
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pallor
Clinical narrative: lightheadedness, nausea, pale, sweating  lay down elevated legs, ice pack, offered H2O monitored symptoms quickly resolved
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Culture, Injection site erythema, Injection site induration, Injection site vesicles
Clinical narrative: Pt developed blisters at the injection site (of MMR) two days after vaccine was given. She also had erythema/firmness at site. She was started on antibiotics pending culture.
Age: 21.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Nausea, Pharyngolaryngeal pain, Sensory disturbance
Clinical narrative: Within 1/2 hour of vaccination, pt c/o feeling nauseous, lightheaded. Place in supine position, legs elevated. BP 96/60. Remained alert, given fluids. Color good. Sent home after seen by MD. Received call from pt in afternoon with additional c/o bad sore throat, strange sensations in legs. Referred to primary care MD who she did see.
Age: 0.3
Sex: M
Vaccine: HIBV
Symptoms: Asthenia, Crying
Clinical narrative: Patient received HIB 02/27/08, mom reports 4 hours later patient cried for 1 hour, then went limp for 1 minute and was weak for 30-60 minutes. 911 was called and assessed the child. Per provider probable breath holding episode.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: L arm-upper painful, swollen and red - area of 7.5 cm x 7.5 cm measured and seen by provider 6/18/08. Advised ice packs/NSAIDS prn and return to clinic if worsens or not improved.
Age: 1.2
Sex: M
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Electroencephalogram normal, Staring, Unresponsive to stimuli
Clinical narrative: On 6/12 when putting child in car after having immunization he seemed to be staring and unresponsive for 1 1/2 minutes. Mother did not think much of it but on 06/21 he had a similar episode witnessed by grandmother who brought him in and notified us. An EEG was normal. There is a family history of seizure disorder.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Had a large red, raised, warm skin reaction at injection starting day after vaccine was administered. 3 days after administration blisters formed on back of each thigh.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Contrast media allergy, Dyspnoea, Rash, Urticaria
Clinical narrative: Urticaria arms and trunk started 6/21/2008 Exam by FM 6/26/08
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Large red area that - swollen and itchy which occurred approximately 12-18 hours after receiving vaccine.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Inappropriate schedule of drug administration, Oedema peripheral, Pyrexia, Urticaria
Clinical narrative: Had shingles shot on 06/13/08. Became very ill 24 hours later. My arm swelled for 4-5 days with welts and I had diarrhea, vomiting and felt feverish. Paid $195.00 to get sick!
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vomiting
Clinical narrative: Had shingles shot on 06/13/08. Became very ill 24 hours later. My arm swelled for 4-5 days with welts and I had diarrhea, vomiting and felt feverish. Paid $195.00 to get sick!
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Inappropriate schedule of drug administration, Injection site erythema, Injection site reaction, Injection site warmth
Clinical narrative: Had shingles shot on 06/13/08. Became very ill 24 hours later. My arm swelled for 4-5 days with welts and I had diarrhea, vomiting and felt feverish. Paid $195.00 to get sick!
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: Had shingles shot on 06/13/08. Became very ill 24 hours later. My arm swelled for 4-5 days with welts and I had diarrhea, vomiting and felt feverish. Paid $195.00 to get sick!
Age: 47.0
Sex: U
Vaccine: TDAP
Symptoms: Pain, Rash, Skin warm
Clinical narrative: Pt obtained TDAP on 6/25/08, developed 5x8 rash on LD. Pt c/o slight pain, warm to touch.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling and warmth at shot site on arm.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Rash pustular
Clinical narrative: 7-1-08 mother called called to report that within 3-4 days of 4-17-08 + 6-17-08, daughter broke out with pustules on her legs, arms, and abdomen. She was brought to PMD on both occasions. He ordered antibiotics and could not give a dx. Pustules resolved within 1-2 wks. Mother seems to think it may be related to HPV vaccine.
Age: 1.3
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Vaccine received r thigh 07/01/08 at 1115 called 7/2/08 3:00 to report entire r thigh swollen and red.
Age: 52.0
Sex: F
Vaccine: HEPA, TYP, YF, HEPA, TYP, YF
Symptoms: Blood folate normal, Differential white blood cell count normal, Full blood count normal, Unevaluable event, Vitamin B12
Clinical narrative: None Stated
Age: 52.0
Sex: F
Vaccine: HEPA, TYP, YF, HEPA, TYP, YF
Symptoms: Blood test normal, Diarrhoea, Dry mouth, Glossodynia, Headache
Clinical narrative: None Stated
Age: 52.0
Sex: F
Vaccine: HEPA, TYP, YF, HEPA, TYP, YF
Symptoms: Nausea, Pain, Tongue disorder, Tongue oedema, Vitamin B12 normal
Clinical narrative: None Stated
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: reaction to vaccine; swelling, redness to upper arm x 1d.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Mass, Oedema peripheral, Rash papular
Clinical narrative: Redness swollen and bumps/lumps on both arms beginning 2 days ago.
Age: 37.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal mass, Anger, Anxiety, Arrhythmia, Arthralgia
Clinical narrative: ache: joint, acid reflux, anxiety, arrhythmia, high cholesterol, leg cramps, dry mouth, energy loss, muscle fatigue, gastritis, migraines, loud noises, lump in right groin, anxious, angry, irritable mood, numbness tingling fingers, pain lower back, groin, back, joint and muscle, chest, rashes, sleep problem, thirst and tiredness
Age: 37.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Back pain, Blood cholesterol increased, Chest pain, Dry mouth
Clinical narrative: ache: joint, acid reflux, anxiety, arrhythmia, high cholesterol, leg cramps, dry mouth, energy loss, muscle fatigue, gastritis, migraines, loud noises, lump in right groin, anxious, angry, irritable mood, numbness tingling fingers, pain lower back, groin, back, joint and muscle, chest, rashes, sleep problem, thirst and tiredness
Age: 37.0
Sex: M
Vaccine: FLUX
Symptoms: Fatigue, Gastritis, Gastrooesophageal reflux disease, Groin pain, Hyperacusis
Clinical narrative: ache: joint, acid reflux, anxiety, arrhythmia, high cholesterol, leg cramps, dry mouth, energy loss, muscle fatigue, gastritis, migraines, loud noises, lump in right groin, anxious, angry, irritable mood, numbness tingling fingers, pain lower back, groin, back, joint and muscle, chest, rashes, sleep problem, thirst and tiredness