chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Dysphonia, Headache, Injection site pain, Malaise, Oropharyngeal pain
Clinical narrative: @10:30am-onset of headache, body aches, mild fever. Lasted all day. 9:30pm began to have scratchy throat, mild body aches and mild headache.  Next morning- 08/11/2012- Woke up at 7:00am with swelled tongue, throat and uvula. Throat felt covered with mucus/film.  Throat felt sore, voice sounded like throat was swelled. Body aches were more severe with feeling of fever.  Called advice nurse and instructed to take 50mg Benadryl..Swelling went away after taking it. 12:30 feeling a little better. Injection site still sore and still not feeling well, but no swelling in throat.
Age: 18.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Pain, Pharyngeal oedema, Pyrexia, Swollen tongue, Throat irritation
Clinical narrative: @10:30am-onset of headache, body aches, mild fever. Lasted all day. 9:30pm began to have scratchy throat, mild body aches and mild headache.  Next morning- 08/11/2012- Woke up at 7:00am with swelled tongue, throat and uvula. Throat felt covered with mucus/film.  Throat felt sore, voice sounded like throat was swelled. Body aches were more severe with feeling of fever.  Called advice nurse and instructed to take 50mg Benadryl..Swelling went away after taking it. 12:30 feeling a little better. Injection site still sore and still not feeling well, but no swelling in throat.
Age: 18.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Headache, Injection site pain, Lip swelling, Malaise, Oropharyngeal pain
Clinical narrative: @10:30am-onset of headache, body aches, mild fever. Lasted all day. 9:30pm began to have scratchy throat, mild body aches and mild headache.  Next morning- 08/11/2012- Woke up at 7:00am with swelled tongue, throat and uvula. Throat felt covered with mucus/film.  Throat felt sore, voice sounded like throat was swelled. Body aches were more severe with feeling of fever.  Called advice nurse and instructed to take 50mg Benadryl..Swelling went away after taking it. 12:30 feeling a little better. Injection site still sore and still not feeling well, but no swelling in throat.
Age: 18.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Pain, Palatal oedema, Pyrexia, Throat irritation, Throat tightness
Clinical narrative: @10:30am-onset of headache, body aches, mild fever. Lasted all day. 9:30pm began to have scratchy throat, mild body aches and mild headache.  Next morning- 08/11/2012- Woke up at 7:00am with swelled tongue, throat and uvula. Throat felt covered with mucus/film.  Throat felt sore, voice sounded like throat was swelled. Body aches were more severe with feeling of fever.  Called advice nurse and instructed to take 50mg Benadryl..Swelling went away after taking it. 12:30 feeling a little better. Injection site still sore and still not feeling well, but no swelling in throat.
Age: 1.62
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Welt at inject site size of pimple, by 8/11 became irregular oval about half inch by inch slightly raised mottled red.
Age: 15.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Body temperature fluctuation, Body temperature increased, Fatigue, Headache
Clinical narrative: Onset of headache over forehead area and feeling tired. Sx progressed into evening and temp of 100.7 - took 400mg ibuprofen. Morning woke up w/ bad headache 7/10 & temp 100.1. 400mg ibuprofen. Headache lasted all day and temp fluctuated btwn 99.9 and 101.2. Third day 8/10: still continued headache upon waking. Took 200 mg ibuprofen, temp 99.7. Sx continuing to persist through this posting.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Myalgia, Pain, Pyrexia
Clinical narrative: EXTREME muscle pain and soreness at injection site. Fever and aches the day after injection.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Injection site erythema, Tenderness
Clinical narrative: Dark Red inflamed area (1 in x 2 inch on skin) by the evening of the injection, tender to touch.  Area around the injection continued to redden for several days, growing to 6 inch diameter area around the injection site. Continued to worsen for about 4 days.  Started improving on day 5 and lasted several more days.  No fever or difficulty breathing.
Age: 10.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Feeling hot, Pain, Pruritus, Swelling
Clinical narrative: 11x11 cm swelling w/ erythema and warmth. Itchy but not very sore until after exam. No streaking, no firm edge. Ice, Ibuprofen.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Decreased appetite, Pruritus, Urticaria
Clinical narrative: PATIENT COMPLAINED OF SEVERE ITCHING ON FACE, NECK, TORSO, ARMS. SHE HAD SMALL TO VERY LARGE (JOINED) HIVES FROM HER HIPS TO HER CHEEKS. SHE WAS QUIET AND DID NOT HAVE AN APPETITE. ITCHING AND HIVES HAVE REAPPEARED DAILY.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Hypotension, Loss of consciousness
Clinical narrative: After flu shot patient started sweating, feeling hot and faint. She said she blacked out for a minute or so. She came round after a few minutes.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Feeling hot, Swelling
Clinical narrative: Pt received pneumonia vaccine 8/10/12 at 11 AM at the clinic. Pt d/c home in NAD. Started swelling in afternoon when she was home then chills stated about 10 PM & and was warm. Pt called at 11 AM spoke with Pt. Pt came to clinic 12 PM (L) arm redness noted from mid arm to mid lower arm & will call this evening will call week 2.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Swelling, redness, flu-like, fever (at inj. site).
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Injection site rash, Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old female patient. The patient was vaccinated with lot # (672612/1653AA) ZOSTAVAX on 06-JUL-2012 and experienced chicken pox like rash at the injection site and localized bruising. The outcome of the events is unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a female patient of unknown age. "About a week ago" on approximately 26-JUL-2012, the patient was vaccinated with a dose of ZOSTAVAX (Lot#, dose and route not reported). No other co-suspects were reported. No concomitant mediations were reported. The patient experienced injection site reaction "later the same day" the patient was administered ZOSTAVAX, which was "about a week ago" on approximately 26-JUL-2012. The injection site reaction was described as a red area at the injection site without pain or swelling (no reported rash). The patient sought for unspecified medical attention. At the time of this report the patient was recovering. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Anaphylactic reaction, Face oedema, Immediate post-injection reaction, Lip oedema, Pharyngeal oedema
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 years old female patient with peanuts allergy, asthma, migraine and allergic rhinitis was vaccinated into right arm with the third dose of GARDASIL (lot #672233/1561AA, expired date 26-AUG-2014) on 23-FEB-2012. Other suspect therapies included VARIVAX (lot# 670248/0420AA, expired date 13-MAR-2013) which vaccinated into left arm. Concomitant medications included acetaminophen, butalbital, FIORICET and albuterol sulfate. On 23-FEB-2012 the patient experienced immediate anaphylaxis after VARIVAX administration. The patient experienced facial, pharynx and lip edema, urticaria to face and trunk, vomited once and fever. The patient was given epinephrine, albuterol sulfate, DECARDRON, DEPO MEDROL, oral steroid and unspecified antihistamines for 7 days. Upon internal review, the events were considered to be medically significant. The patient's outcome was unknown. This report was considered not serious, ER visit by the agency. The original reporting source was not provided. The VAERS ID# is 450968-1. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Pyrexia, Urticaria, 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 15 years old female patient with peanuts allergy, asthma, migraine and allergic rhinitis was vaccinated into right arm with the third dose of GARDASIL (lot #672233/1561AA, expired date 26-AUG-2014) on 23-FEB-2012. Other suspect therapies included VARIVAX (lot# 670248/0420AA, expired date 13-MAR-2013) which vaccinated into left arm. Concomitant medications included acetaminophen, butalbital, FIORICET and albuterol sulfate. On 23-FEB-2012 the patient experienced immediate anaphylaxis after VARIVAX administration. The patient experienced facial, pharynx and lip edema, urticaria to face and trunk, vomited once and fever. The patient was given epinephrine, albuterol sulfate, DECARDRON, DEPO MEDROL, oral steroid and unspecified antihistamines for 7 days. Upon internal review, the events were considered to be medically significant. The patient's outcome was unknown. This report was considered not serious, ER visit by the agency. The original reporting source was not provided. The VAERS ID# is 450968-1. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash, Rash erythematous, Rash pruritic
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 17 year old female patient with family history Hashimoto's thyroiditis was vaccinated in left arm with the third dose of GARDASIL (lot number 672193/1524AA, route unknown) on 27-FEB-2012. On 28-FEB-2012, day after last vaccine 3rd dose of GARDASIL patient developed itchy pink bump above bikini line, under umbilicus, and at inner thigh. Resolved. On 08-MAR-2012 the patient developed itchy pink bump at right hip area. The listing indicated that one or more of the events was considered to be not serious. No further information is available. The original reporting source was not provided. The VAERS ID# was 451560.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash erythematous, Rash pruritic
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 17 year old female patient with family history Hashimoto's thyroiditis was vaccinated in left arm with the third dose of GARDASIL (lot number 672193/1524AA, route unknown) on 27-FEB-2012. On 28-FEB-2012, day after last vaccine 3rd dose of GARDASIL patient developed itchy pink bump above bikini line, under umbilicus, and at inner thigh. Resolved. On 08-MAR-2012 the patient developed itchy pink bump at right hip area. The listing indicated that one or more of the events was considered to be not serious. No further information is available. The original reporting source was not provided. The VAERS ID# was 451560.
Age: 42.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Vitiligo
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 42 years old male patient with anal/penile dysplasia at the time of vaccine and with medical history of HPV infection treated intramuscularly with the third dose of GARDASIL (lot# 1487Y) on 26-JAN-2010. The patient experienced a rapid onset of progressive vitiligo, following a 3-part course of GARDASIL, per dosing schedule. Condition persists. Patient was in treatment through a number of modalities. Symptoms began within 2-3 weeks of administration of GARDASIL. No further information is available. The original reporting source was not provided. The VAERS ID # is 451964-1.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Erythema, Induration, Oedema peripheral
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 was vaccinated in the right arm with the first dose of GARDASIL (lot # 672232/1495AA) on 20-MAR-2012. Other suspect vaccine included ADACEL (lot# C4051AA) in the left arm on 20-MAR-2012. Concomitant vaccine included: MENVEO (lot# A10058). On 21-MAR-2012 the patient experienced left arm red and swollen with 12cm x 10cm and firm swelling. BENADRYL 25mg 1-6 hours and hydrocortisone cream 2.5mg 4x a day PRN were given for the events. The outcome of the left arm red and swollen with 12cm x 10cm and firm swelling was unknown. The patient sought medical attention. The reporter felt that left arm red and swollen with 12cm x 10cm and firm swelling were non-serious. The original reporting source was not provided. The VAERS ID # is 452392-1. Additional information is not expected.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Cold sweat, Dizziness, Feeling abnormal, Gaze palsy, Musculoskeletal stiffness
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 (VAERS #453074-1). A 16 years old male patient had mono "a month ago" approximately on 05-MAR-2012 was vaccinated with GARDASIL (lot # 665607/1333Y) (vaccination site unknown) intramuscular on 05-APR-2012. The patient was also given HAVRIX (AHAV10522BA) (vaccination site unknown) intramuscular on 05-APR-2012. On 05-APR-2012 after vaccination the patient began to shake, eyes rolled to the back of his head, his body stiffened and legs contracted. He could not hear for a brief time. His skin became cool and clammy and then warm. He became dizzy at the onset and told the reporter something was wrong. The reporter lowered him to the floor, supporting his head, approved a cool towel to his forehead, told him to breathe and relax, and starting taking vitals. The incident took only a few moments. But reporter placed him on table at a 45 degree angle as he still complained of dizziness, nausea and feeling "weird". The reporter observed him for one hour recording blood pressure and pulse, lowest blood pressure was 90/50 and pulse ran in the upper 60's. At time of the report, the patient's outcome was unknown. No further information is available. The original reporting source was not provided.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Nausea, Skin warm, 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 (VAERS #453074-1). A 16 years old male patient had mono "a month ago" approximately on 05-MAR-2012 was vaccinated with GARDASIL (lot # 665607/1333Y) (vaccination site unknown) intramuscular on 05-APR-2012. The patient was also given HAVRIX (AHAV10522BA) (vaccination site unknown) intramuscular on 05-APR-2012. On 05-APR-2012 after vaccination the patient began to shake, eyes rolled to the back of his head, his body stiffened and legs contracted. He could not hear for a brief time. His skin became cool and clammy and then warm. He became dizzy at the onset and told the reporter something was wrong. The reporter lowered him to the floor, supporting his head, approved a cool towel to his forehead, told him to breathe and relax, and starting taking vitals. The incident took only a few moments. But reporter placed him on table at a 45 degree angle as he still complained of dizziness, nausea and feeling "weird". The reporter observed him for one hour recording blood pressure and pulse, lowest blood pressure was 90/50 and pulse ran in the upper 60's. At time of the report, the patient's outcome was unknown. No further information is available. The original reporting source was not provided.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Cold sweat, Dizziness, Extremity contracture, Feeling abnormal, Gaze palsy
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 (VAERS #453074-1). A 16 years old male patient had mono "a month ago" approximately on 05-MAR-2012 was vaccinated with GARDASIL (lot # 665607/1333Y) (vaccination site unknown) intramuscular on 05-APR-2012. The patient was also given HAVRIX (AHAV10522BA) (vaccination site unknown) intramuscular on 05-APR-2012. On 05-APR-2012 after vaccination the patient began to shake, eyes rolled to the back of his head, his body stiffened and legs contracted. He could not hear for a brief time. His skin became cool and clammy and then warm. He became dizzy at the onset and told the reporter something was wrong. The reporter lowered him to the floor, supporting his head, approved a cool towel to his forehead, told him to breathe and relax, and starting taking vitals. The incident took only a few moments. But reporter placed him on table at a 45 degree angle as he still complained of dizziness, nausea and feeling "weird". The reporter observed him for one hour recording blood pressure and pulse, lowest blood pressure was 90/50 and pulse ran in the upper 60's. At time of the report, the patient's outcome was unknown. No further information is available. The original reporting source was not provided.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Hypoacusis, Hypotension, Musculoskeletal stiffness, Nausea, Skin warm
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 (VAERS #453074-1). A 16 years old male patient had mono "a month ago" approximately on 05-MAR-2012 was vaccinated with GARDASIL (lot # 665607/1333Y) (vaccination site unknown) intramuscular on 05-APR-2012. The patient was also given HAVRIX (AHAV10522BA) (vaccination site unknown) intramuscular on 05-APR-2012. On 05-APR-2012 after vaccination the patient began to shake, eyes rolled to the back of his head, his body stiffened and legs contracted. He could not hear for a brief time. His skin became cool and clammy and then warm. He became dizzy at the onset and told the reporter something was wrong. The reporter lowered him to the floor, supporting his head, approved a cool towel to his forehead, told him to breathe and relax, and starting taking vitals. The incident took only a few moments. But reporter placed him on table at a 45 degree angle as he still complained of dizziness, nausea and feeling "weird". The reporter observed him for one hour recording blood pressure and pulse, lowest blood pressure was 90/50 and pulse ran in the upper 60's. At time of the report, the patient's outcome was unknown. No further information is available. The original reporting source was not provided.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: 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 (VAERS #453074-1). A 16 years old male patient had mono "a month ago" approximately on 05-MAR-2012 was vaccinated with GARDASIL (lot # 665607/1333Y) (vaccination site unknown) intramuscular on 05-APR-2012. The patient was also given HAVRIX (AHAV10522BA) (vaccination site unknown) intramuscular on 05-APR-2012. On 05-APR-2012 after vaccination the patient began to shake, eyes rolled to the back of his head, his body stiffened and legs contracted. He could not hear for a brief time. His skin became cool and clammy and then warm. He became dizzy at the onset and told the reporter something was wrong. The reporter lowered him to the floor, supporting his head, approved a cool towel to his forehead, told him to breathe and relax, and starting taking vitals. The incident took only a few moments. But reporter placed him on table at a 45 degree angle as he still complained of dizziness, nausea and feeling "weird". The reporter observed him for one hour recording blood pressure and pulse, lowest blood pressure was 90/50 and pulse ran in the upper 60's. At time of the report, the patient's outcome was unknown. No further information is available. The original reporting source was not provided.
Age: 25.0
Sex: F
Vaccine: HPV4, TD, HPV4, TD
Symptoms: Arthralgia, Discomfort, Lethargy, Lymphadenopathy, Malaise
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 25 year old female patient with no medical history and no prex-illness was vaccinated with the first dose of GARDASIL (lot number unknown) into the right arm on 23-MAR-2012. On the same day, the patient was vaccinated with a dose of Td (manufacturer and lot number not reported) into the left arm. Concomitant medications included NUVARING, multi-vitamins (unspecified), vitamin D3, and acidophilus. The day of the vaccine, the patient experienced swollen lymph node under the left underarm. The patient developed cold, and began to become lethargic and sick for once week. Since then, the patient had been experienced chronic joint and muscle aches in her arms, shoulders, hands, lower back, neck, legs and feet. The patient tried icing these areas and taking joint supplements, but the pain and discomfort would not abate. The patient never experienced this chronic pain until after she began to take the GARDASIL vaccine. At the time of reporting, the outcome was unknown. No further information is available. The original reporting source was not provided. The VAERS ID #: 453964-1.
Age: 25.0
Sex: F
Vaccine: HPV4, TD, HPV4, TD
Symptoms: Myalgia, Nasopharyngitis
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 25 year old female patient with no medical history and no prex-illness was vaccinated with the first dose of GARDASIL (lot number unknown) into the right arm on 23-MAR-2012. On the same day, the patient was vaccinated with a dose of Td (manufacturer and lot number not reported) into the left arm. Concomitant medications included NUVARING, multi-vitamins (unspecified), vitamin D3, and acidophilus. The day of the vaccine, the patient experienced swollen lymph node under the left underarm. The patient developed cold, and began to become lethargic and sick for once week. Since then, the patient had been experienced chronic joint and muscle aches in her arms, shoulders, hands, lower back, neck, legs and feet. The patient tried icing these areas and taking joint supplements, but the pain and discomfort would not abate. The patient never experienced this chronic pain until after she began to take the GARDASIL vaccine. At the time of reporting, the outcome was unknown. No further information is available. The original reporting source was not provided. The VAERS ID #: 453964-1.
Age: 25.0
Sex: F
Vaccine: HPV4, TD, HPV4, TD
Symptoms: Myalgia, Nasopharyngitis, 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 concerning a 25 year old female patient with no medical history and no prex-illness was vaccinated with the first dose of GARDASIL (lot number unknown) into the right arm on 23-MAR-2012. On the same day, the patient was vaccinated with a dose of Td (manufacturer and lot number not reported) into the left arm. Concomitant medications included NUVARING, multi-vitamins (unspecified), vitamin D3, and acidophilus. The day of the vaccine, the patient experienced swollen lymph node under the left underarm. The patient developed cold, and began to become lethargic and sick for once week. Since then, the patient had been experienced chronic joint and muscle aches in her arms, shoulders, hands, lower back, neck, legs and feet. The patient tried icing these areas and taking joint supplements, but the pain and discomfort would not abate. The patient never experienced this chronic pain until after she began to take the GARDASIL vaccine. At the time of reporting, the outcome was unknown. No further information is available. The original reporting source was not provided. The VAERS ID #: 453964-1.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Injection site erythema, Injection site pain, 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 (VAERS #454443-1). A 14 years old female without previous illness was vaccinated with the second dose of GARDASIL (lot # 665607/1333Y) on the right arm on 09-JAN-2012. Other suspect therapies included VARIVAX (Merck) (Lot# 0863AA) on the right arm on 09-JAN-2012. Concomitant medications included: ZOLOFT. On 10-JAN-2012, the patient was viewed pictures of painful red swollen upper arm (right) following the second dose of GARDASIL, that took 1 week to resolve. Small reaction after the first dose of GARDASIL. At time of the report, the patient's outcome was recovered. Additional information is not expected.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Headache, Injection site rash, Injection site urticaria, 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 in the left arm with the first dose of GARDASIL, lot # 672834/0131AE) on 29-MAY-2012 and other suspect vaccine MENACTRA, (lot # U3906AB, Dose 2) in the right arm on 29-MAY-2012. Concomitant medications included ZYRTEC and PROAIR. On 29-MAY-2012 in the evening, it was noticed that the patient experienced shoulder itch and rash, hive/rash 10cm x 12cm in right (R) deltoid. On 31-MAY-2012 3:00 PM the patient had an exam and was diagnosed of headache. At the time of reporting, the patient's outcome was unknown. The original reporting source was not provided. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Hypoaesthesia, Oedema peripheral
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 19 year old female patient with no pertinent medical history or any previous illness was vaccinated intramuscularly into the right arm with first dose of GARDASIL (lot # 672834/0131AE) on 30-MAY-2012. On the same day, the patient was also vaccinated intramuscularly into the left arm with first dose of MENACTRA (lot # U4247AA). No concomitant medications were reported. The patient experienced hypoaesthesia and oedema peripheral on 30-MAY-2012. Approximately 25 minutes after receiving vaccinations, patient reported back to immunization clinic complaining of raised swollen spot on her left hand that was numb. After administering BENADRYL and observing patient for another 45 minutes with provider supervision, patient felt fine. The listing indicated that the events were not serious. No further information is available. The original reporting source was not provided.
Age: 17.0
Sex: F
Vaccine: HPV4, IPV, MNQ, HPV4, IPV, MNQ, HPV4, IPV, MNQ
Symptoms: Cellulitis, Erythema, Induration
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 17 year old female patient was vaccinated intramuscularly into the left arm with GARDASIL (lot # 668670/0476AA) on 04-JUN-2012. On the same day, patient was given intramuscularly into the left arm IPOL (lot # H1200) and vaccinated subcutaneously into the right arm with MENVEO (lot # M10056). On 04-JUN-2012 the patient experienced cellulitis, induration and erythema. Within first 24 hours of vaccination, the patient developed erythema and induration which had continued to increase in size. VS stable. The patient was placed on KEFLEX oral for cellulitis. The listing indicated that the events were not serious. No further information is available. The original reporting source was not provided. The VAERS ID was 456950.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection-site redness and swelling for approximately 2 weeks after administration.
Age: 11.0
Sex: M
Vaccine: HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Mother called stating child has just developed a red nonraised nonitching rash all over body Md instructed mother to give Benadryl oral and Tylenol oral.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Headache
Clinical narrative: Pain in right upper face and head comes and goes. Pain continues.  Tylenol.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: Soreness, redness, "knot" at injection site.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Injection site inflammation, Injection site pain, Injection site reaction, Nausea
Clinical narrative: Started with pain and inflammation of the left deltoid muscle, soreness of muscle and a feeling of nausea and lightheadedness at noon on 7/26/12.  Symptoms of nausea and lightheadedness continued all day 7/26 and until ~ 1 PM on 7/27.  Swelling did not resolve until 8/30/12.  Pain and inflammation was relieved by ibuprofen 200mg every 6-8 hours as needed.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Started with pain and inflammation of the left deltoid muscle, soreness of muscle and a feeling of nausea and lightheadedness at noon on 7/26/12.  Symptoms of nausea and lightheadedness continued all day 7/26 and until ~ 1 PM on 7/27.  Swelling did not resolve until 8/30/12.  Pain and inflammation was relieved by ibuprofen 200mg every 6-8 hours as needed.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Ear pain, Eye pain, Nasal congestion, Nasopharyngitis
Clinical narrative: Started with post-nasal drip and coughing.  Turned into a cold. Sore throat. Nasal and chest congestion. Sore eyes. Sore ear.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Respiratory tract congestion, Upper-airway cough syndrome
Clinical narrative: Started with post-nasal drip and coughing.  Turned into a cold. Sore throat. Nasal and chest congestion. Sore eyes. Sore ear.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Injection area is very swollen, red and hot. my whole body aches, I'm very drowsy and it hurts to move or lift my arm.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Somnolence
Clinical narrative: Injection area is very swollen, red and hot. my whole body aches, I'm very drowsy and it hurts to move or lift my arm.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: Soreness in arm, couldn't straighten, hot, red area, about the size on an adult hand on underside of arm, a few inches from injection site.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy, Dermatomyositis, Dysphagia, Muscular weakness, Rash
Clinical narrative: Trouble swallowing followed by gradual muscle weakness in upper body and mild rash on skin of fingers dermatomyositis diagnosed by my dermatologist and by a rheumatologist.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Aspiration bone marrow normal, Biopsy bone marrow normal, Eating disorder, Fatigue, Growth retardation
Clinical narrative: Son had a several fevers throughout the month of May after his shots were administered that were 100 or higher. He stopped eating regularly as well, and stopped gaining weight. In July 2012 almost two months after his shots he was diagnosed with neutropenia, not sure what kind. Was admitted to hospital in July and he received antibiotics and fluids. He had not gained weight, grown in height and was more tired than usual throughout the month of June.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Neutropenia, Neutrophil count decreased, Pyrexia, Weight gain poor
Clinical narrative: Son had a several fevers throughout the month of May after his shots were administered that were 100 or higher. He stopped eating regularly as well, and stopped gaining weight. In July 2012 almost two months after his shots he was diagnosed with neutropenia, not sure what kind. Was admitted to hospital in July and he received antibiotics and fluids. He had not gained weight, grown in height and was more tired than usual throughout the month of June.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Dyspepsia, Nausea, Pain, Pyrexia
Clinical narrative: Awoke from sleep at 1am to uncharacteristic nausea and indigestion. Went back to sleep at 5am. Awoke at 9am and soon after began to have chills. Fever to 102F and severe body aches for the rest of the day until 2am the next morning.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site reaction, Irritability, Local reaction, Pyrexia, Screaming
Clinical narrative: Prolonged, excessive irritability & screaming spells, fever & local reaction injection site lasting greater than 72 hrs. Similar reaction after initial vaccine series lasting 1-2 weeks (by parental history).
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site swelling, Pyrexia, Tremor
Clinical narrative: Fever (103). Chilling/shaking. Swelling at injection site.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pain, Pruritus
Clinical narrative: Patient received Zoster vaccine on 8/2/12 in left arm subq. Came back in on 8/6/12 with blister size of quarter or better and red around. Called patient MD and set a visit for today for MD to check. Sore, redness, itching, blistered.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Induration, Nausea, Pyrexia, Urticaria, Vomiting
Clinical narrative: Hives, nausea/vomiting, local muscle induration w/ in 24 hours. Fevers approximately 8 hours after vaccines.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling & erythema at (L) upper arm approximately 9 x 5 cm.
Age: 17.0
Sex: F
Vaccine: MMR
Symptoms: Human chorionic gonadotropin positive, Inappropriate schedule of drug administration, Maternal exposure during pregnancy
Clinical narrative: Pt. received MMR at 3-4 weeks gestation with LMP of 4/16/12, which wasn't diagnosed until June 20th with (+) HCG. She also had no records at time of vaccination which revealed 2 prior MMR vaccines.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood cholesterol, Blood test, Full blood count, Urine analysis, Urticaria
Clinical narrative: This spontaneous report has been received from a consumer who was a 68 years old male patient with amoxicillin allergy, coronary artery disease and medical history of knee surgery and dental surgery. The patient was vaccinated SC with a dose of ZOSTAVAX on 26-JUL-2012. No other co-suspects were reported. Concomitant medications included aspirin, multivitamins, fish oil, fosinopril sodium and lovastatin (manufacturer unknown). On 27-JUL-2012 the patient developed welts on his rib cage while on ZOSTAVAX. The patient stated that he previously took amoxicillin and developed hives. The patient did not seek medical attention. No treatment information was reported. Cholesterol test, blood panel, urine analysis and complete blood count were performed. The outcome of event was reported as not recovered/not resolved. Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Injection site swelling, Injection site warmth, Oedema peripheral, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 years old female patient with hypertension and depression and a history of "urinary continence". The patient was vaccinated with 0.5 ml PNEUMOVAX23 (Lot number was reported as "H8009826") intramuscular onto right arm on 31-JUL-2012. No other co-suspects were reported. Concomitant medications included metoprolol, ACTONEL, LEXAPRO and VESICARE. In the night of 31-JUL-2012, the patient had a fever. In addition she had swelling (not only at the injection site but spread throughout her right arm, pain (not only the right arm, but generalized pain throughout her body like the flu) and warmth at the injection site. The patient was in pharmacy at the time of reporting and the pharmacist advised the patient to follow up with her health care provider. Pharmacist stated that patient was treated with TYLENOL and cold packs at the injection site as needed. The outcome was reported as not recovered/not resolved. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 years old female patient with hypertension and depression and a history of "urinary continence". The patient was vaccinated with 0.5 ml PNEUMOVAX23 (Lot number was reported as "H8009826") intramuscular onto right arm on 31-JUL-2012. No other co-suspects were reported. Concomitant medications included metoprolol, ACTONEL, LEXAPRO and VESICARE. In the night of 31-JUL-2012, the patient had a fever. In addition she had swelling (not only at the injection site but spread throughout her right arm, pain (not only the right arm, but generalized pain throughout her body like the flu) and warmth at the injection site. The patient was in pharmacy at the time of reporting and the pharmacist advised the patient to follow up with her health care provider. Pharmacist stated that patient was treated with TYLENOL and cold packs at the injection site as needed. The outcome was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (lot # 670616/0617AA) on 04-AUG-2012 after its expiration date (26-JUL-2012). No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. The patient was vaccinated with GARDASIL (lot number unknown). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced nausea, fever and body aches. The patient had sought unspecified medical attention. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to one of her 3 grandchildren of unknown age. It was reported that the patient may have received GARDASIL (lot # not reported) outside of the closing schedule. The reporter was unaware of the dates when the patient received the GARDASIL injections. No adverse effect reported. Whether the patient sought for medical attention was not reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from an other health professional refers to unknown number of patients of unknown age. The patients were vaccinated with VAQTA which was stored as low as 24F on multiple occasions. No treatment information was reported. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. All telephone attempts to obtain follow-up information have been unsuccessful.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a male consumer refers to himself of unknown age. The patient's drug reactions/allergies was none. The patient's medical history included hernia surgery, surgery on his veins and legs, tonsillitis and tonsillectomy. The patient was subcutaneously vaccinated with a 0.65 ml dose of ZOSTAVAX (lot# not reported) on 02-AUG-2012. No other co-suspects were reported. No concomitant medications were included. On 02-AUG-2012 the patient experienced shingles, 1 day after onset of therapy. The patient did not seek medical attention. No treatment information was given for the adverse event. The outcome of shingles was reported as not recovered/not resolved. The relatedness for shingles is unknown for ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Atrial fibrillation, Herpes zoster
Clinical narrative: This spontaneous report as received from a male consumer refers to himself of unknown age. The patient's drug reactions/allergies was none. The patient's medical history included hernia surgery, surgery on his veins and legs, tonsillitis and tonsillectomy. The patient was subcutaneously vaccinated with a 0.65 ml dose of ZOSTAVAX (lot# not reported) on 02-AUG-2012. No other co-suspects were reported. No concomitant medications were included. On 02-AUG-2012 the patient experienced shingles, 1 day after onset of therapy. The patient did not seek medical attention. No treatment information was given for the adverse event. The outcome of shingles was reported as not recovered/not resolved. The relatedness for shingles is unknown for ZOSTAVAX. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Chest pain, Electrocardiogram
Clinical narrative: This spontaneous report as received from nurse refers to a 73 years old female patient. The patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot # not reported) on 19-JUL-2012. On 19-JUL-2012 after being vaccinated, the patient developed chest pain and anxiety. It was reported that the patient did an EKG. And the patient sought for medical attention when she was at the office at that time. The physician did not think the AE had anything to do with ZOSTAVAX because the patient was normally anxious. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age. The patient was vaccinated with the first dose of RECOMBIVAX HB (lot# not provided) 1 ml intramuscular on 01-FEB-2012. No other co-suspects were reported. No concomitant medications were reported. On 02-AUG-2012 the patient received the second dose of RECOMBIVAX HB (lot# not provided) 1 ml intramuscular. No adverse event reported. It was unknown if the patient sought medical attention. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (lot # 670616/0617AA) on 31-JUL-2012 after its expiration date (26-JUL-2012). No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (lot # 670616/0617AA) on 29-JUL-2012 after its expiration date (26-JUL-2012). No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. The patient was vaccinated with GARDASIL on an unknown date (lot# and route were unspecified). On an unknown date the patient experienced nausea, fever and body aches. The outcome of body aches, fever and nausea was unknown. The patient sought unspecified medical attention. This is one of several reports received from the same source (1208USA001866 and 1208USA001869). Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. The patient was vaccinated with GARDASIL on an unknown date (lot # and route were unspecified). On an unknown date the patient experienced nausea, fever and body aches. The outcome of body aches, fever and nausea was unknown. The patient sought unspecified medical attention. This is one of several reports received from the same source (1208USA001866 and 1208USA001868). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered pharmacist concerning a couple of patients who were vaccinated with ZOSTAVAX (Merck) (lot# not reported) and then got shingles. The pharmacist did not know the specific number of patients. At the time of reporting, the patients' outcome was unknown. All telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information has been received from the pharmacist. She mentioned in the letter that she could not provide more information about the adverse reaction. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from an other health professional refers to unknown number of patients of unknown age. The patients were vaccinated with RECOMBIVAX HB 0.5ml which was stored as low as 24F on multiple occasions. No treatment information was reported. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. All telephone attempts to obtain follow-up information have been unsuccessful.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from an other health professional refers to unknown number of patients of unknown age. The patients were vaccinated with LIQUID PEDVAXHIB which was stored as low as 24F on multiple occasions. No treatment information was reported. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.