chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: U
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Diagnostic procedure, Dizziness, Laboratory test normal, Pallor, Tremor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 11 years old patient with allergic rhinitis, poor appetite and no pre-existing illness at the time of vaccination. The patient was vaccinated intramuscularly with lot # (671994/1537AA) dose 1 of GARDASIL (dose not reported) on 15-MAY-2012. No other co-suspects were reported. Concomitant medications included dose 1 of MENACTRA (lot # H4030AA) IM and dose 1 of Tdap (lot # U4106BA) IM. No other concomitant medications were reported. On 15-MAY-2012 a few minutes after GARDASIL the patient felt faint became pale and shaky, the patient was given cake and was laid down, vitals remained good. The episode passed in about 10 minutes. No treatment information was reported. The outcome of shaky, felt faint and became pale was reported as recovered/resolved. The relatedness for the reported events was not provided for GARDASIL. The original reporting source was not provided. The VAERS ID # is 456039. This report was considered non serious and no conditions by the agency. Additional information is not expected.
Age: 14.0
Sex: M
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Dizziness, Nausea
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 14 years old male patient with asthma, allergies to pollen and no pre-existing illness at the time of vaccination. The patient was vaccinated intramuscularly in the left arm with lot # (671463/1359AA) dose 3 of GARDASIL (dose not reported) on 21-MAY-2012. Other suspect therapies included dose 2 of VARIVAX (Merck) (lot number 671431/1631AA; dose not reported) subcutaneously on 21-MAY-2012. Concomitant medication included; albuterol prn for sports. On 21-MAY-2012 the patient felt lightheaded and nausea. Temperature and blood pressure were fine. Juice drink was given and the patient laid down. The patient was sent home with mother. Drank g-ale and soup, slept for 3 hours and felt better when he woke up. The patient felt fine the next day. It was stated that no medical care was needed and no lab diagnostic tests were performed. The relatedness for felt lightheaded and nausea was not provided for VARIVAX (Merck) and GARDASIL. The original reporting source was not provided. The VAERS ID # is 456137. This report was considered non serious and no conditions by the agency. Additional information is not expected.
Age: 14.0
Sex: M
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Dizziness, Laboratory test normal, Nausea
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 14 years old male patient with asthma, allergies to pollen and no pre-existing illness at the time of vaccination. The patient was vaccinated intramuscularly in the left arm with lot # (671463/1359AA) dose 3 of GARDASIL (dose not reported) on 21-MAY-2012. Other suspect therapies included dose 2 of VARIVAX (Merck) (lot number 671431/1631AA; dose not reported) subcutaneously on 21-MAY-2012. Concomitant medication included; albuterol prn for sports. On 21-MAY-2012 the patient felt lightheaded and nausea. Temperature and blood pressure were fine. Juice drink was given and the patient laid down. The patient was sent home with mother. Drank g-ale and soup, slept for 3 hours and felt better when he woke up. The patient felt fine the next day. It was stated that no medical care was needed and no lab diagnostic tests were performed. The relatedness for felt lightheaded and nausea was not provided for VARIVAX (Merck) and GARDASIL. The original reporting source was not provided. The VAERS ID # is 456137. This report was considered non serious and no conditions by the agency. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, HPV4
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: This report was identified from a line listing on request by the Company from the FDA under the Freedom of Information Act. On 16-MAR-2012, an 11 year old male was vaccinated with a dose of GARDASIL and a doe of MENACTRA into the right arm. On 17-MAR-2012, the patient experienced right upper arm area of light erythema. No increased warmth but slightly indurated. At the time of report, the patient's outcome was unknown. The adverse events were considered to be no conditions, not serious. No further information is available. The original reporting source was not provided. The VAERS ID # is 456212.
Age: 16.0
Sex: M
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Blister, Chills, Pain, Rash pruritic, Scab
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 years old male patient was vaccinated subcutaneously into left arm with lot # (671427/1217AA) second dose of VARIVAX (Merck) on 09-MAY-2012. Other suspect therapies included the first dose of GARDASIL (Lot #670049/1261AA) vaccinated IM into left arm on 09-MAY-2012. No concomitant medications were reported. Patient developed rash with onset on Saturday 19-MAY-2012 in the morning before 8AM. The spots looked like mosquito bites and were itchy. Then on Sunday 20-SEP-2012 he had more and some turned into blisters. That same night he had chills, vomiting, body aches. On 21-SEP-2012 he had some more spots, more than 50 spots. Some blisters are already scabbing. He was diagnosed clinically with varicella on 20-MAY-2012 at a local urgent care. No further information is available. The original reporting source was not provided.
Age: 16.0
Sex: M
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Varicella post vaccine, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 years old male patient was vaccinated subcutaneously into left arm with lot # (671427/1217AA) second dose of VARIVAX (Merck) on 09-MAY-2012. Other suspect therapies included the first dose of GARDASIL (Lot #670049/1261AA) vaccinated IM into left arm on 09-MAY-2012. No concomitant medications were reported. Patient developed rash with onset on Saturday 19-MAY-2012 in the morning before 8AM. The spots looked like mosquito bites and were itchy. Then on Sunday 20-SEP-2012 he had more and some turned into blisters. That same night he had chills, vomiting, body aches. On 21-SEP-2012 he had some more spots, more than 50 spots. Some blisters are already scabbing. He was diagnosed clinically with varicella on 20-MAY-2012 at a local urgent care. No further information is available. The original reporting source was not provided.
Age: 16.0
Sex: M
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Blister, Chills, Pain, Pruritus, Rash
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 years old male patient was vaccinated subcutaneously into left arm with lot # (671427/1217AA) second dose of VARIVAX (Merck) on 09-MAY-2012. Other suspect therapies included the first dose of GARDASIL (Lot #670049/1261AA) vaccinated IM into left arm on 09-MAY-2012. No concomitant medications were reported. Patient developed rash with onset on Saturday 19-MAY-2012 in the morning before 8AM. The spots looked like mosquito bites and were itchy. Then on Sunday 20-SEP-2012 he had more and some turned into blisters. That same night he had chills, vomiting, body aches. On 21-SEP-2012 he had some more spots, more than 50 spots. Some blisters are already scabbing. He was diagnosed clinically with varicella on 20-MAY-2012 at a local urgent care. No further information is available. The original reporting source was not provided.
Age: 16.0
Sex: M
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Scab, Varicella post vaccine, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 years old male patient was vaccinated subcutaneously into left arm with lot # (671427/1217AA) second dose of VARIVAX (Merck) on 09-MAY-2012. Other suspect therapies included the first dose of GARDASIL (Lot #670049/1261AA) vaccinated IM into left arm on 09-MAY-2012. No concomitant medications were reported. Patient developed rash with onset on Saturday 19-MAY-2012 in the morning before 8AM. The spots looked like mosquito bites and were itchy. Then on Sunday 20-SEP-2012 he had more and some turned into blisters. That same night he had chills, vomiting, body aches. On 21-SEP-2012 he had some more spots, more than 50 spots. Some blisters are already scabbing. He was diagnosed clinically with varicella on 20-MAY-2012 at a local urgent care. No further information is available. The original reporting source was not provided.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Oedema peripheral, Rash, Swelling face
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 10 years old female patient with medical history included asthma who on 21-MAY-2012 was vaccinated with the first dose of GARDASIL (Lot 671006/1291AA, intramuscular on right arm, dose not reported). Concomitant medications included ADACEL (Lot#C3927AA, intramuscular on left arm) and the first dose of MENACTRA (Lot#U4074BA, intramuscular on left arm), which were given on the same day. On21-MAY-2012 the patient experienced swelling to hand and cheeks and rash to cheeks, rash to neck. The patient sought medical attention by ER visit. At the time of reporting, the outcomes were unknown. The original reporting source was unknown. The VAERS ID # 456318.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 years old male patient with allergic to bee sting who on 01-JUN-2012 was vaccinated with the first dose of GARDASIL (lot # not reported, intramuscular on left arm, dose not reported). Secondary suspect therapies included the first dose of MENACTRA (Lot# U3904AA, intramuscular on the right arm, dose not reported) given on the same day. On an unspecified date the patient was vaccinated with a dose of Tdap. On 01-JUL-2012, the patient experienced injection site rash, red and elevated area on left deltoid, increased warmth at site of MENACTRA injection. At the time of reporting, the outcomes were unknown. The original reporting source was unknown. The VAERS ID# 456650. It was reported that the patient's experiences were considered non-serious.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 years old male patient with allergic to bee sting who on 01-JUN-2012 was vaccinated with the first dose of GARDASIL (lot # not reported, intramuscular on left arm, dose not reported). Secondary suspect therapies included the first dose of MENACTRA (Lot# U3904AA, intramuscular on the right arm, dose not reported) given on the same day. On an unspecified date the patient was vaccinated with a dose of Tdap. On 01-JUL-2012, the patient experienced injection site rash, red and elevated area on left deltoid, increased warmth at site of MENACTRA injection. At the time of reporting, the outcomes were unknown. The original reporting source was unknown. The VAERS ID# 456650. It was reported that the patient's experiences were considered non-serious.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Eye swelling, Lip swelling, Pruritus, Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 years old female patient with no medical history and no prex illness who on 31-MAY-2012 was vaccinated with the first dose of GARDASIL (lot # 671006/1291AA, dose and route not reported) to left deltoid. Concomitant medications included the first dose of BOOSTRIX (Lot#AC52B074AA, right arm deltoid) and the first dose of MENACTRA (Lot# U4072BA, right arm deltoid). Per patient's mother reported. Approximately 1 hour after vaccines patient broke out with hives, itching and swelling to left eye and lips. At the time of reporting, the outcomes were unknown. The original reporting source was the patient's mother. It was reported that the patient's experiences were considered non-serious. The VAERS ID# 456672.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Chills, Erythema, Headache, Injection site erythema, Injection site swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 years old female patient with no prex illness who on 15-MAY-2012 was vaccinated with the first dose of GARDASIL (lot # 670049/1171AA, intramuscular on right arm, dose not reported). Secondary suspect therapies included the first dose of VARIVAX (Merck) (Lot# 670325/0608AA, sq on the right arm, dose not reported) given on 15-MAY-2012. Concomitant medications included the first dose of HAVRIX (Lot# AHAVB4938A, intramuscular on right arm, dose not reported) BOOSTRIX (Lot# AC52B076AA, intramuscular on left arm, dose not reported) and MENACTRA (Lot# U3842AA, intramuscular on left arm, dose not reported), which were given on the same day. And ATARAX 25mg, TID, prn. At the time of reporting, the outcomes were unknown. The original reporting source was unknown. The VAERS ID# 456729. It was reported that the patient's experiences were considered non-serious.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 years old female patient with no prex illness who on 15-MAY-2012 was vaccinated with the first dose of GARDASIL (lot # 670049/1171AA, intramuscular on right arm, dose not reported). Secondary suspect therapies included the first dose of VARIVAX (Merck) (Lot# 670325/0608AA, sq on the right arm, dose not reported) given on 15-MAY-2012. Concomitant medications included the first dose of HAVRIX (Lot# AHAVB4938A, intramuscular on right arm, dose not reported) BOOSTRIX (Lot# AC52B076AA, intramuscular on left arm, dose not reported) and MENACTRA (Lot# U3842AA, intramuscular on left arm, dose not reported), which were given on the same day. And ATARAX 25mg, TID, prn. At the time of reporting, the outcomes were unknown. The original reporting source was unknown. The VAERS ID# 456729. It was reported that the patient's experiences were considered non-serious.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Unevaluable event
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 years old female patient with no prex illness who on 15-MAY-2012 was vaccinated with the first dose of GARDASIL (lot # 670049/1171AA, intramuscular on right arm, dose not reported). Secondary suspect therapies included the first dose of VARIVAX (Merck) (Lot# 670325/0608AA, sq on the right arm, dose not reported) given on 15-MAY-2012. Concomitant medications included the first dose of HAVRIX (Lot# AHAVB4938A, intramuscular on right arm, dose not reported) BOOSTRIX (Lot# AC52B076AA, intramuscular on left arm, dose not reported) and MENACTRA (Lot# U3842AA, intramuscular on left arm, dose not reported), which were given on the same day. And ATARAX 25mg, TID, prn. At the time of reporting, the outcomes were unknown. The original reporting source was unknown. The VAERS ID# 456729. It was reported that the patient's experiences were considered non-serious.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act, concerning a 11 years old female patient. The patient was vaccinated intramuscularly into the left arm with the third dose of GARDASIL (lot # 672232/1495AA) on 07-JUN-2012. On the same day the patient experienced nausea and dizziness. And it was reported that nausea and lightheadedness resolved in 20 minutes with BP90/50, HR64, RR20 rested and H2O given. The original reporting source was not provided. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Dizziness, Dyskinesia, Fatigue, Feeling abnormal, Injection site pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 year old female with no previous illness and no medical history on 07-JUN-2012 was vaccinated IM into left arm with first dose of GARDASIL (lot # 665607/1332Y) and the first dose of ADACEL (lot  # 64305AA). No other medication administered. Patient (pt) was very anxious about receiving vaccines RN (registered nurse) administered a ADACEL IM in the deltoid of her left arm. Pt stated that it hurt. RN then administered an GARDASIL an inch lower in the same arm. Pt stated that it didn't hurt, it just felt weird. Pt then became very pale and stated that she was going to pass out. She was sitting upright in a chair. RN has slide down and rested her head on the back of the chair. Pt then just turned her head and fainted for about 2 seconds. During this time her legs and arms straightened out. Her mom got a cool cloth. She was assisted to the floor where she laid for about 10 minutes. She then sat in the chair for another 5 minutes. Her color came back and she stated she felt exhausted, but fine. RN gave her cell phone number and instructions to go to the ER (emergency room) if any concerns. RN gave info on the imms given and where they where given. RN test pt the next morning and she stated that she had just finished basketball practice and was feeling fine. No conditions, no lab data provided. The original reporting source was not provided. The VAERS ID # is 457248.
Age: 15.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Injection site reaction, Pallor, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 year old female with no previous illness and no medical history on 07-JUN-2012 was vaccinated IM into left arm with first dose of GARDASIL (lot # 665607/1332Y) and the first dose of ADACEL (lot  # 64305AA). No other medication administered. Patient (pt) was very anxious about receiving vaccines RN (registered nurse) administered a ADACEL IM in the deltoid of her left arm. Pt stated that it hurt. RN then administered an GARDASIL an inch lower in the same arm. Pt stated that it didn't hurt, it just felt weird. Pt then became very pale and stated that she was going to pass out. She was sitting upright in a chair. RN has slide down and rested her head on the back of the chair. Pt then just turned her head and fainted for about 2 seconds. During this time her legs and arms straightened out. Her mom got a cool cloth. She was assisted to the floor where she laid for about 10 minutes. She then sat in the chair for another 5 minutes. Her color came back and she stated she felt exhausted, but fine. RN gave her cell phone number and instructions to go to the ER (emergency room) if any concerns. RN gave info on the imms given and where they where given. RN test pt the next morning and she stated that she had just finished basketball practice and was feeling fine. No conditions, no lab data provided. The original reporting source was not provided. The VAERS ID # is 457248.
Age: 15.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Fatigue, Feeling abnormal, Injection site pain, Injection site reaction, Pallor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 year old female with no previous illness and no medical history on 07-JUN-2012 was vaccinated IM into left arm with first dose of GARDASIL (lot # 665607/1332Y) and the first dose of ADACEL (lot  # 64305AA). No other medication administered. Patient (pt) was very anxious about receiving vaccines RN (registered nurse) administered a ADACEL IM in the deltoid of her left arm. Pt stated that it hurt. RN then administered an GARDASIL an inch lower in the same arm. Pt stated that it didn't hurt, it just felt weird. Pt then became very pale and stated that she was going to pass out. She was sitting upright in a chair. RN has slide down and rested her head on the back of the chair. Pt then just turned her head and fainted for about 2 seconds. During this time her legs and arms straightened out. Her mom got a cool cloth. She was assisted to the floor where she laid for about 10 minutes. She then sat in the chair for another 5 minutes. Her color came back and she stated she felt exhausted, but fine. RN gave her cell phone number and instructions to go to the ER (emergency room) if any concerns. RN gave info on the imms given and where they where given. RN test pt the next morning and she stated that she had just finished basketball practice and was feeling fine. No conditions, no lab data provided. The original reporting source was not provided. The VAERS ID # is 457248.
Age: 15.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 year old female with no previous illness and no medical history on 07-JUN-2012 was vaccinated IM into left arm with first dose of GARDASIL (lot # 665607/1332Y) and the first dose of ADACEL (lot  # 64305AA). No other medication administered. Patient (pt) was very anxious about receiving vaccines RN (registered nurse) administered a ADACEL IM in the deltoid of her left arm. Pt stated that it hurt. RN then administered an GARDASIL an inch lower in the same arm. Pt stated that it didn't hurt, it just felt weird. Pt then became very pale and stated that she was going to pass out. She was sitting upright in a chair. RN has slide down and rested her head on the back of the chair. Pt then just turned her head and fainted for about 2 seconds. During this time her legs and arms straightened out. Her mom got a cool cloth. She was assisted to the floor where she laid for about 10 minutes. She then sat in the chair for another 5 minutes. Her color came back and she stated she felt exhausted, but fine. RN gave her cell phone number and instructions to go to the ER (emergency room) if any concerns. RN gave info on the imms given and where they where given. RN test pt the next morning and she stated that she had just finished basketball practice and was feeling fine. No conditions, no lab data provided. The original reporting source was not provided. The VAERS ID # is 457248.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Unevaluable event
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 years old male patient with hypertension, obesity and previous illness of cough was vaccinated with a first dose of GARDASIL, left arm (lot # 672232/1495AA) (dose and route were unknown) on 07-JUN-2012 and a first dose of MENACTRA, right arm (batch # U4096AA) (dose and route were unknown) on 07-JUN-2012. Concomitant medications included loratadine. It was reported that on 07-JUN-2012 the patient experienced unevaluable event, 0 day after onset of therapy. No treatment information was reported. The outcome of unevaluable event was unknown. This report was considered non serious with not conditions by the agency. The original reporting source was not provided. The VAERS ID # is 457727-1. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: HPV4, MEN, TDAP, HPV4, MNQ, TDAP
Symptoms: Erythema, Injection site urticaria, Oedema peripheral, Urticaria
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 years old male patient on 14-JUN-2012 was vaccinated IM with a dose of GARDASIL (lot # reported as 1696AA) into the left arm. No other co-suspects were reported. Concomitant vaccines given on the same day included a dose of MENOMUNE (lot # U4021AE) into the right arm and an IM dose of BOOSTRIX into the left arm (lot # AC52B075BA). A 19-JUN-2012 5 days after onset of therapy, the patient experienced hives on his legs, abdomen and on right deltoid where vaccine was administered. The patient had redness and swelling on the right arm. At the time of the report, the patient's outcome was not reported. The patient required an emergency room visit. This report was considered non serious by the agency. The original reporting source was not provided. The VAERS ID # is 457927. Additional information is not expected.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Limb discomfort, Pain in extremity, Skin induration, Skin mass, Skin warm
Clinical narrative: This spontaneous report has been received from a Healthcare student refers to a 52 years old female patient with no pertinent medical history or drug allergy who was vaccinated SC with a dose of ZOSTAVAX (Exp Date: 21-MAR-2013) on 31-JUL-2012. No other co-suspects were reported. Concomitant medications included chlorpromazine, quetiapine fumarate, LANTUS, docusate sodium, levothyroxine sodium, albuterol sulfate, COMBIVENT, metformin, methadone hydrochloride, clonazepam, gabapentin and CYMBALTA. On an unknown date the patient developed an injection site reaction after receiving a dose of ZOSTAVAX. The patient had pain in the arm and large red area around the injection site. The patient told the reporter that she felt that there's a "grapefruit" under her arm at the site of the injection. The patient sought medical attention by calling pharmacist. There was no lab diagnostics performed. The outcome of event was reported as not recovered/not resolved. Additional information is not expected.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site reaction, Pain in extremity
Clinical narrative: This spontaneous report has been received from a Healthcare student refers to a 52 years old female patient with no pertinent medical history or drug allergy who was vaccinated SC with a dose of ZOSTAVAX (Exp Date: 21-MAR-2013) on 31-JUL-2012. No other co-suspects were reported. Concomitant medications included chlorpromazine, quetiapine fumarate, LANTUS, docusate sodium, levothyroxine sodium, albuterol sulfate, COMBIVENT, metformin, methadone hydrochloride, clonazepam, gabapentin and CYMBALTA. On an unknown date the patient developed an injection site reaction after receiving a dose of ZOSTAVAX. The patient had pain in the arm and large red area around the injection site. The patient told the reporter that she felt that there's a "grapefruit" under her arm at the site of the injection. The patient sought medical attention by calling pharmacist. There was no lab diagnostics performed. The outcome of event was reported as not recovered/not resolved. Additional information is not expected.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, Injection site pain, Mobility decreased, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: This spontaneous report was received from medical assistant refers to a 60 years old male patient with hypercholesterolemia and hypertension and without drug reactions/allergies. The patient was vaccinated intramuscularly with a single dose of ZOSTAVAX (lot # 671021/0747AA) on 02-AUG-2012. Concomitant therapies included lisinopril (manufacturer unknown) and unspecified cholesterol medication. On 02-AUG-2012 the patient experienced severe muscle spasms of the right arm since administration of ZOSTAVAX. The right arm was difficult and painful to lift. The patient is in the office on 09-AUG-2012, but had not yet been evaluated by the physician at the time of the report. There was no lab diagnostics studies performed. The outcome of severe muscle spasms of the right arm was reported as not recovered. The patient sought medical attention by visiting the office. All adverse events were considered to be disabled by the reporter. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Mobility decreased, Muscle spasms, Pain
Clinical narrative: This spontaneous report was received from medical assistant refers to a 60 years old male patient with hypercholesterolemia and hypertension and without drug reactions/allergies. The patient was vaccinated intramuscularly with a single dose of ZOSTAVAX (lot # 671021/0747AA) on 02-AUG-2012. Concomitant therapies included lisinopril (manufacturer unknown) and unspecified cholesterol medication. On 02-AUG-2012 the patient experienced severe muscle spasms of the right arm since administration of ZOSTAVAX. The right arm was difficult and painful to lift. The patient is in the office on 09-AUG-2012, but had not yet been evaluated by the physician at the time of the report. There was no lab diagnostics studies performed. The outcome of severe muscle spasms of the right arm was reported as not recovered. The patient sought medical attention by visiting the office. All adverse events were considered to be disabled by the reporter. Additional information has been requested.
Age: 1.26
Sex: F
Vaccine: HIBV, PPV, HIBV, PNC
Symptoms: Crying, Injection site urticaria, Poor quality sleep, Vomiting
Clinical narrative: 8/14 developed hives extensively at thigh and migrated to arms & trunks 8/13/12 vomited all night, 6 hours after injection next day, developed fever & hives.
Age: 1.26
Sex: F
Vaccine: HIBV, PPV, HIBV, PNC
Symptoms: Pyrexia, Urticaria, Vomiting
Clinical narrative: 8/14 developed hives extensively at thigh and migrated to arms & trunks 8/13/12 vomited all night, 6 hours after injection next day, developed fever & hives.
Age: 40.0
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Fibromyalgia, Myalgia
Clinical narrative: SEVERE Fibromyalgia-like symptoms, constant fever of 101, achy muscles, brain fog, exhaustion, tender and sore joints.
Age: 40.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: SEVERE Fibromyalgia-like symptoms, constant fever of 101, achy muscles, brain fog, exhaustion, tender and sore joints.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: 2 inch thin red line at injection site.  Spread to about 1 inch wide. Itchy and warm to the touch.  Feels bumpy and warm.
Age: 1.98
Sex: F
Vaccine: MMR, PNC13
Symptoms: Wrong drug administered
Clinical narrative: PENTACEL and MMR vaccines were ordered by dr. However patient received PREVNAR 13 and MMR instead. Vaccines were ordered on 08-20-11 and discovery was made on 08-07-12 by dr.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Pt developed swelling, redness & hot to touch 24 hrs post vaccination. Pt was placed on oral antibiotics, with no improvement. Symptoms increased, pt was sent to hospital for eval.
Sex: F
Vaccine: DTAP, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site warmth, Oedema peripheral, Rash
Clinical narrative: This spontaneous report received from a registered nurse who is the patient. The patient was vaccinated with a 0.65 ml dose of ZOSTAVAX. Concomitant therapy included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown). The patient reported that she got the ZOSTAVAX vaccine and had a reaction. On 31-JUL-2012 her arm got really red and swollen and she developed a rash that spread down to her arm. Also the patient's injection site had redness and was warm to the touch. The patient went to the doctor for medical attention. No lab diagnostics studies were performed. The arm swollen was considered to be an important medical event since the patient did ice packs to keep her arm from swelling. The outcome of the events was reported as recovering. Additional information has been requested.
Age: 0.82
Sex: M
Vaccine: HEP, PNC13
Symptoms: Irritability, Pyrexia
Clinical narrative: PCV13 & Hep B yesterday at 8-14-12 at 4:30. Fever of 103 degrees last night. 102 degrees all day today. No symptoms other than fussiness. Mom home from work with him. 8/16/12 fever decreased. Went back to school per mom.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Rash, Rash macular, Skin warm
Clinical narrative: Large red, warm 14 cm irregular rash with splotchy red macular eruption beyond primary site. Also small splotchy red macular spots on thighs.
Sex: F
Vaccine: HPV4
Symptoms: Nervous system disorder
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. The patient was respectively vaccinated IM. with first, second and third dose of GARDASIL, 0.5ml, in month 0, months 2 and month 6. No other co-suspects were reported. No concomitant medications were reported. 10 days after the third dose, the patient experienced neurological problem and was hospitalized. Patient was hospitalized at hospital. The outcome of neurological problem was unknown. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Angioedema, Biopsy skin, Computerised tomogram, Dyspnoea, Dyspnoea exertional
Clinical narrative: Information has been received from a physician via complete VZV questionnaire concerning a 64 year old female patient with peanut, soy and adhesive tape allergies and a history of chickenpox at childhood who on 19-MAR-2012 was vaccinated SQ in the left upper arm with a dose of ZOSTAVAX, 0.65ml (lot # 670816/0693AA). The physician mentioned that "2-3" days after vaccine administration, on approximately 21-MAR-2012 the patient got red, itchy, hot, swelling around the injection site about 1/4 inch to 3 inch in diameter, which lasted 2 weeks. On 21-MAR-2012, the patient got rash, swelling, hives and shortness of breath. The rash type was described as hives with a number of lesions of 10-20 on body, numerous times for the past 4 weeks of the time of report. The patient had no recent exposure to chickenpox. The patient went to the emergency room of an unidentified hospital for treatment and was prescribed prednisone (manufacturer unknown). At the time of the report, the patient was recovering, still having hives but improving on therapy. Other adverse effect's outcome was unknown. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine strain. A papula sample was collected on 16-MAY-2012. The sample was taken from the patient's right chest wall. The PCR result from the right chest wall specimen was inadequate specimen. The VZV DNA was not amplified. The beta-flobin DNA was not amplified. Follow up information has been received from a physician, refers to a 64 year old female patient (clerk) with none illness at the time of vaccination and none pre-existing allergies, birth defects and medical conditions (in previous version it was reported that patient has peanut, soy and adhesive tape allergies) who on 19-MAR-2012 was vaccinated subcutaneously in left upper arm with a dose of ZOSTAVAX, (dose not reported) Lot#670816/0693AA) by a pharmacy technician. On 21-Mar-2012 the patient experienced hives, shortness of breath, dyspnea on exertion and angioedema for 6 weeks post vaccination. It was reported that the patient required emergency room/doctor visit. CT scan, skin biopsy and unspecified lab test were performed (results not provided). On an unspecified date in June 2012 the patient recovered from hives, shortness of breath, dyspnea on exertion and angioedema. Reported terms "hives, shortness of breath, dyspnea on exertion and angioedema" were considered as disability and important medical events by reporter. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Laboratory test
Clinical narrative: Information has been received from a physician via complete VZV questionnaire concerning a 64 year old female patient with peanut, soy and adhesive tape allergies and a history of chickenpox at childhood who on 19-MAR-2012 was vaccinated SQ in the left upper arm with a dose of ZOSTAVAX, 0.65ml (lot # 670816/0693AA). The physician mentioned that "2-3" days after vaccine administration, on approximately 21-MAR-2012 the patient got red, itchy, hot, swelling around the injection site about 1/4 inch to 3 inch in diameter, which lasted 2 weeks. On 21-MAR-2012, the patient got rash, swelling, hives and shortness of breath. The rash type was described as hives with a number of lesions of 10-20 on body, numerous times for the past 4 weeks of the time of report. The patient had no recent exposure to chickenpox. The patient went to the emergency room of an unidentified hospital for treatment and was prescribed prednisone (manufacturer unknown). At the time of the report, the patient was recovering, still having hives but improving on therapy. Other adverse effect's outcome was unknown. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine strain. A papula sample was collected on 16-MAY-2012. The sample was taken from the patient's right chest wall. The PCR result from the right chest wall specimen was inadequate specimen. The VZV DNA was not amplified. The beta-flobin DNA was not amplified. Follow up information has been received from a physician, refers to a 64 year old female patient (clerk) with none illness at the time of vaccination and none pre-existing allergies, birth defects and medical conditions (in previous version it was reported that patient has peanut, soy and adhesive tape allergies) who on 19-MAR-2012 was vaccinated subcutaneously in left upper arm with a dose of ZOSTAVAX, (dose not reported) Lot#670816/0693AA) by a pharmacy technician. On 21-Mar-2012 the patient experienced hives, shortness of breath, dyspnea on exertion and angioedema for 6 weeks post vaccination. It was reported that the patient required emergency room/doctor visit. CT scan, skin biopsy and unspecified lab test were performed (results not provided). On an unspecified date in June 2012 the patient recovered from hives, shortness of breath, dyspnea on exertion and angioedema. Reported terms "hives, shortness of breath, dyspnea on exertion and angioedema" were considered as disability and important medical events by reporter. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Polymerase chain reaction, Rash, Swelling, Urticaria, Varicella virus test negative
Clinical narrative: Information has been received from a physician via complete VZV questionnaire concerning a 64 year old female patient with peanut, soy and adhesive tape allergies and a history of chickenpox at childhood who on 19-MAR-2012 was vaccinated SQ in the left upper arm with a dose of ZOSTAVAX, 0.65ml (lot # 670816/0693AA). The physician mentioned that "2-3" days after vaccine administration, on approximately 21-MAR-2012 the patient got red, itchy, hot, swelling around the injection site about 1/4 inch to 3 inch in diameter, which lasted 2 weeks. On 21-MAR-2012, the patient got rash, swelling, hives and shortness of breath. The rash type was described as hives with a number of lesions of 10-20 on body, numerous times for the past 4 weeks of the time of report. The patient had no recent exposure to chickenpox. The patient went to the emergency room of an unidentified hospital for treatment and was prescribed prednisone (manufacturer unknown). At the time of the report, the patient was recovering, still having hives but improving on therapy. Other adverse effect's outcome was unknown. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine strain. A papula sample was collected on 16-MAY-2012. The sample was taken from the patient's right chest wall. The PCR result from the right chest wall specimen was inadequate specimen. The VZV DNA was not amplified. The beta-flobin DNA was not amplified. Follow up information has been received from a physician, refers to a 64 year old female patient (clerk) with none illness at the time of vaccination and none pre-existing allergies, birth defects and medical conditions (in previous version it was reported that patient has peanut, soy and adhesive tape allergies) who on 19-MAR-2012 was vaccinated subcutaneously in left upper arm with a dose of ZOSTAVAX, (dose not reported) Lot#670816/0693AA) by a pharmacy technician. On 21-Mar-2012 the patient experienced hives, shortness of breath, dyspnea on exertion and angioedema for 6 weeks post vaccination. It was reported that the patient required emergency room/doctor visit. CT scan, skin biopsy and unspecified lab test were performed (results not provided). On an unspecified date in June 2012 the patient recovered from hives, shortness of breath, dyspnea on exertion and angioedema. Reported terms "hives, shortness of breath, dyspnea on exertion and angioedema" were considered as disability and important medical events by reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Infertility female
Clinical narrative: This spontaneous report as received from a consumer's boyfriend consumer refers to a female patient of unknown age who on an unspecified date was vaccinated with a dose of GARDASIL (lot #, dose and site of administration were not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient experienced infertility and she could not carry a child after the first trimester (medically significant). At the time of the report, the patient's outcome was not reported. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: DTAP, FLU3, HEP, MMR, VARCEL
Symptoms: Local swelling, Musculoskeletal stiffness, Neck pain
Clinical narrative: Pt complain of Rt side neck swelling, pain and stiffness.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Fainted for few seconds. Laid back on exam table & applied cool cloths to forehead & neck B/P 110/70/5 min later 96/60; feeling fine within 5 min & left clinic ambulatory.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling abnormal, Pruritus, Urticaria
Clinical narrative: 2:00 pm - Tdap (L) deltoid; 2:15pm - itching bilateral hands/feet, "feeling funny"; 2:30 - BENADRYL 50mg PO; 2:45 - full trunk urticaria, bilateral upper extremity; 3:15pm - 125mg SOLU-MEDROL IM; 3:45 - Slight improvement (PO Prednisone 40mg qd x 5 days sent).
Age: 66.0
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Urticaria
Clinical narrative: Red flat circular wells whole body - no itching.
Age: 2.0
Sex: F
Vaccine: DTAP, HEP, HEPA
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (L) thigh, red, hot, and swollen very painful size of softball. Pt very guarded. Onset 1 day after vaccine worse 2 days. Treated with ice, massage, BENADRYL, and TYLENOL.
Age: 1.02
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Computerised tomogram head normal, Convulsion, Dyskinesia, Full blood count normal, Metabolic function test normal
Clinical narrative: Seizure not associated with fever occurring within 24 hrs of vaccines listed below. Full body jerking lasting 5-7 minutes, followed by postictal period (10-15 minutes).
Age: 1.02
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Postictal state, Urine analysis normal
Clinical narrative: Seizure not associated with fever occurring within 24 hrs of vaccines listed below. Full body jerking lasting 5-7 minutes, followed by postictal period (10-15 minutes).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Erythema, Local reaction, Skin warm
Clinical narrative: Localized rxn (pink-red, warm to touch, not painful- circular patch.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: He developed a rash over most of his body (not head) that was itchy the first day so he took BENADRYL- he had the shot 1 week previously - it went away after 3 days.
Age: 53.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Cellulitis, Inflammation, Local reaction
Clinical narrative: Cellulitis vs Local Inflammatory Reaction. Treated with antibiotics (KEFLEX).
Age: 1.57
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Rash generalised, Rash papular
Clinical narrative: Generalized papulo vesicular rash, diff stages of healing.
Age: 1.46
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Erythema, Rash, Swelling
Clinical narrative: Red (day 1). Swelling (day 2). Bumps, swelling, red (day 3). Bigger bumps, swelling red (day 4).
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Urticaria
Clinical narrative: Client presented with Mom to health dept approximately 24 hours after immunization inoculation with 3 1/2 x 4 inch welt (LA). Client and Mom denied fever, vomiting, diarrhea and hives. Referred client to ER. Called Mom for follow up. ER physician recommended BENADRYL and cold compress. Welt was gone next morning. Physician recommends next doses with BENADRYL.
Age: 58.0
Sex: F
Vaccine: HEPAB, MMR, TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: 35 mm redness and swelling left arm denies any pain. 8/13/12 14:22- made reports redness and swelling almost completely gone- denies any pain.
Age: 13.0
Sex: F
Vaccine: HPV4, MMR, MNQ, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Syncope after immunizations.
Age: 45.0
Sex: F
Vaccine: VARCEL
Symptoms: Diarrhoea, Fatigue, Nausea, Pain, Pain in extremity
Clinical narrative: Fever, body aches, fatigue, nausea, rash, arm pain, diarrhea.
Age: 45.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever, body aches, fatigue, nausea, rash, arm pain, diarrhea.
Age: 14.0
Sex: M
Vaccine: IPV, MMR, TD, VARCEL
Symptoms: Syncope
Clinical narrative: Syncope after immunizations.
Age: 1.37
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13
Symptoms: Rash, Rash macular
Clinical narrative: 8/15/12 Phone call from mother, child has blotchy rash on legs, arms and face. Acting normal. Referred to doctor for evaluation. Mom to take her and call with results.
Age: 10.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Syncope
Clinical narrative: Syncope after immunizations.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuritis, Pain in extremity, Tenderness
Clinical narrative: Severe neuritis (no redness, swelling) but severe lancinating pain down vaccinated arm - sensitive to light touch & pressure Tx with Acyclovir 800 5x /d, NEURONTIN 300 qd VICODIN prn.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema multiforme, Rash
Clinical narrative: Erythema multiforme rash - diffuse.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Injection site swelling, Pruritus, Pyrexia, Urticaria
Clinical narrative: Fever/chills, itching/hives, swollen arm, around injection site, vomiting.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Fever/chills, itching/hives, swollen arm, around injection site, vomiting.