chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Initial report received on 07 September 2011 from another manufacturer, report #WAES 1108USA03448. The initial reporter to his manufacturer had been a health care professional. The VAERS ID# 427694. Verbatim from the report: "This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 6 month old male patient with none medical history or preexisting illness (patient status reported as "well") was vaccinated with the third dose of ROTATEQ, oral, (lot # reported as 669830/0078AA) on 20 June 2011. Concomitant therapy, given on the same date included third dose of PENTACEL, (Lot C3842AA) and third dose of PREVNAR 13 (Lot 916005). It was reported that the patient developed frequent vomiting on 02 July 2011 followed with abdominal distension and lethargy. It was confirmed ileocolic intussusception and required surgical reduction on 05 July 2011. The following information was obtained through follow-up and/or provided by the government. On 28 July 2011 primary care professional records received for Office visits/treatments completed from 20 June 2011 to 04 July 2011. The patient returned on 03 July 2011 with complained of vomiting and decreased appetite. Exam within normal limits (WNL) except for shotty nodes. Discharged home. It was noted that parent made several calls to primary care physician (PCP) on 04 July 2011 with complained of fever, abdominal distension and decreased activity level with increased sleep. Voiding decreased. Patient was referred to an ER. At the time of the report, the patient's outcome was unknown. The original reporting source was not provided. This report was considered serious by the agency due to hospitalization. No further information is available." Documents held by sender: None.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Decreased appetite, Hypotonia, Micturition disorder, Mobility decreased, Muscular weakness
Clinical narrative: Initial report was received on 21 September 2011 from a consumer who is also the patient's parent. A two-month old female patient who had no illness at the time of vaccination had received on 20 September 2011 an intramuscular left thigh injection of PENTACEL (lot number not reported) and on 21 September 2011, the patient woke from a nap screaming non stop for four hours, had a poor appetite, urinated twice in 24 hours, arms and legs seemed limp or weakened and shoulders were moving but arms remained at the patient's sides. According to the parent, the patient extremity weakness was a prolonged symptom. The parent reported that all symptoms had resolved at the time of the initial report but then called back to report that "she still see some weakness in the left arm and leg today". No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Screaming
Clinical narrative: Initial report was received on 21 September 2011 from a consumer who is also the patient's parent. A two-month old female patient who had no illness at the time of vaccination had received on 20 September 2011 an intramuscular left thigh injection of PENTACEL (lot number not reported) and on 21 September 2011, the patient woke from a nap screaming non stop for four hours, had a poor appetite, urinated twice in 24 hours, arms and legs seemed limp or weakened and shoulders were moving but arms remained at the patient's sides. According to the parent, the patient extremity weakness was a prolonged symptom. The parent reported that all symptoms had resolved at the time of the initial report but then called back to report that "she still see some weakness in the left arm and leg today". No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Biopsy bone marrow normal, Biopsy muscle abnormal, Blood lactate dehydrogenase normal, Computerised tomogram abdomen normal, Computerised tomogram normal
Clinical narrative: Initial report was received from the scientific literature on 25 June 2012. The following is verbatim from the report: "A 67-year-old woman developed a MALT lymphoma in the same area that she had previously received an influenza virus vaccine injection. The woman received an influenza virus vaccination (dosage not stated) in her right arm and, 1 month later, she developed pain and a lump at the same site. Initially, she was thought to have a torn triceps muscle but a subsequent MRI of her right upper arm revealed a 4.3 x 1.1 x 7.5cm enhancing mass in the posterolateral region of the long head of the right triceps muscle. A core biopsy showed small B-cell type low grade lymphoma and an incisional biopsy showed B-cell-type lymphoma infiltrating the skeletal muscle. Immunohistochemical staining was consistent with marginal zone lymphoma. She was staged 1 E and was given an International Prognostic Index score of 1. The woman underwent radiation therapy and, on physical examination at 1 and 6 months and 1 year following treatment, she had no palpable residual mass, skin erythema or swelling, and no range of motion deficits. An MRI of her right arm, conducted 6 months after treatment, showed no residual disease. Author comment: Whether or not our patient's triceps MALT was coincidental or related to her influenza vaccinations remains undetermined." The patient's outcome was not reported. Documents held by sender: None.
Age: 67.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Computerised tomogram thorax normal, Extranodal marginal zone B-cell lymphoma (MALT type), Immunohistochemistry, Injection site mass, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Initial report was received from the scientific literature on 25 June 2012. The following is verbatim from the report: "A 67-year-old woman developed a MALT lymphoma in the same area that she had previously received an influenza virus vaccine injection. The woman received an influenza virus vaccination (dosage not stated) in her right arm and, 1 month later, she developed pain and a lump at the same site. Initially, she was thought to have a torn triceps muscle but a subsequent MRI of her right upper arm revealed a 4.3 x 1.1 x 7.5cm enhancing mass in the posterolateral region of the long head of the right triceps muscle. A core biopsy showed small B-cell type low grade lymphoma and an incisional biopsy showed B-cell-type lymphoma infiltrating the skeletal muscle. Immunohistochemical staining was consistent with marginal zone lymphoma. She was staged 1 E and was given an International Prognostic Index score of 1. The woman underwent radiation therapy and, on physical examination at 1 and 6 months and 1 year following treatment, she had no palpable residual mass, skin erythema or swelling, and no range of motion deficits. An MRI of her right arm, conducted 6 months after treatment, showed no residual disease. Author comment: Whether or not our patient's triceps MALT was coincidental or related to her influenza vaccinations remains undetermined." The patient's outcome was not reported. Documents held by sender: None.
Age: 67.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Radiotherapy, Vaccination site pain
Clinical narrative: Initial report was received from the scientific literature on 25 June 2012. The following is verbatim from the report: "A 67-year-old woman developed a MALT lymphoma in the same area that she had previously received an influenza virus vaccine injection. The woman received an influenza virus vaccination (dosage not stated) in her right arm and, 1 month later, she developed pain and a lump at the same site. Initially, she was thought to have a torn triceps muscle but a subsequent MRI of her right upper arm revealed a 4.3 x 1.1 x 7.5cm enhancing mass in the posterolateral region of the long head of the right triceps muscle. A core biopsy showed small B-cell type low grade lymphoma and an incisional biopsy showed B-cell-type lymphoma infiltrating the skeletal muscle. Immunohistochemical staining was consistent with marginal zone lymphoma. She was staged 1 E and was given an International Prognostic Index score of 1. The woman underwent radiation therapy and, on physical examination at 1 and 6 months and 1 year following treatment, she had no palpable residual mass, skin erythema or swelling, and no range of motion deficits. An MRI of her right arm, conducted 6 months after treatment, showed no residual disease. Author comment: Whether or not our patient's triceps MALT was coincidental or related to her influenza vaccinations remains undetermined." The patient's outcome was not reported. Documents held by sender: None.
Age: 67.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: BCL-2 gene status assay, Biopsy bone marrow normal, Biopsy muscle abnormal, Blood lactate dehydrogenase normal, Computerised tomogram abdomen normal
Clinical narrative: Initial report was received from the scientific literature on 25 June 2012. The following is verbatim from the report: "A 67-year-old woman developed a MALT lymphoma in the same area that she had previously received an influenza virus vaccine injection. The woman received an influenza virus vaccination (dosage not stated) in her right arm and, 1 month later, she developed pain and a lump at the same site. Initially, she was thought to have a torn triceps muscle but a subsequent MRI of her right upper arm revealed a 4.3 x 1.1 x 7.5cm enhancing mass in the posterolateral region of the long head of the right triceps muscle. A core biopsy showed small B-cell type low grade lymphoma and an incisional biopsy showed B-cell-type lymphoma infiltrating the skeletal muscle. Immunohistochemical staining was consistent with marginal zone lymphoma. She was staged 1 E and was given an International Prognostic Index score of 1. The woman underwent radiation therapy and, on physical examination at 1 and 6 months and 1 year following treatment, she had no palpable residual mass, skin erythema or swelling, and no range of motion deficits. An MRI of her right arm, conducted 6 months after treatment, showed no residual disease. Author comment: Whether or not our patient's triceps MALT was coincidental or related to her influenza vaccinations remains undetermined." The patient's outcome was not reported. Documents held by sender: None.
Age: 67.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Computerised tomogram normal, Computerised tomogram thorax normal, Extranodal marginal zone B-cell lymphoma (MALT type) stage I, Immunohistochemistry, Injection site mass
Clinical narrative: Initial report was received from the scientific literature on 25 June 2012. The following is verbatim from the report: "A 67-year-old woman developed a MALT lymphoma in the same area that she had previously received an influenza virus vaccine injection. The woman received an influenza virus vaccination (dosage not stated) in her right arm and, 1 month later, she developed pain and a lump at the same site. Initially, she was thought to have a torn triceps muscle but a subsequent MRI of her right upper arm revealed a 4.3 x 1.1 x 7.5cm enhancing mass in the posterolateral region of the long head of the right triceps muscle. A core biopsy showed small B-cell type low grade lymphoma and an incisional biopsy showed B-cell-type lymphoma infiltrating the skeletal muscle. Immunohistochemical staining was consistent with marginal zone lymphoma. She was staged 1 E and was given an International Prognostic Index score of 1. The woman underwent radiation therapy and, on physical examination at 1 and 6 months and 1 year following treatment, she had no palpable residual mass, skin erythema or swelling, and no range of motion deficits. An MRI of her right arm, conducted 6 months after treatment, showed no residual disease. Author comment: Whether or not our patient's triceps MALT was coincidental or related to her influenza vaccinations remains undetermined." The patient's outcome was not reported. Documents held by sender: None.
Age: 67.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Injection site pain, Injection site reaction, Laboratory test abnormal, Muscle mass, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Initial report was received from the scientific literature on 25 June 2012. The following is verbatim from the report: "A 67-year-old woman developed a MALT lymphoma in the same area that she had previously received an influenza virus vaccine injection. The woman received an influenza virus vaccination (dosage not stated) in her right arm and, 1 month later, she developed pain and a lump at the same site. Initially, she was thought to have a torn triceps muscle but a subsequent MRI of her right upper arm revealed a 4.3 x 1.1 x 7.5cm enhancing mass in the posterolateral region of the long head of the right triceps muscle. A core biopsy showed small B-cell type low grade lymphoma and an incisional biopsy showed B-cell-type lymphoma infiltrating the skeletal muscle. Immunohistochemical staining was consistent with marginal zone lymphoma. She was staged 1 E and was given an International Prognostic Index score of 1. The woman underwent radiation therapy and, on physical examination at 1 and 6 months and 1 year following treatment, she had no palpable residual mass, skin erythema or swelling, and no range of motion deficits. An MRI of her right arm, conducted 6 months after treatment, showed no residual disease. Author comment: Whether or not our patient's triceps MALT was coincidental or related to her influenza vaccinations remains undetermined." The patient's outcome was not reported. Documents held by sender: None.
Age: 67.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Radiotherapy
Clinical narrative: Initial report was received from the scientific literature on 25 June 2012. The following is verbatim from the report: "A 67-year-old woman developed a MALT lymphoma in the same area that she had previously received an influenza virus vaccine injection. The woman received an influenza virus vaccination (dosage not stated) in her right arm and, 1 month later, she developed pain and a lump at the same site. Initially, she was thought to have a torn triceps muscle but a subsequent MRI of her right upper arm revealed a 4.3 x 1.1 x 7.5cm enhancing mass in the posterolateral region of the long head of the right triceps muscle. A core biopsy showed small B-cell type low grade lymphoma and an incisional biopsy showed B-cell-type lymphoma infiltrating the skeletal muscle. Immunohistochemical staining was consistent with marginal zone lymphoma. She was staged 1 E and was given an International Prognostic Index score of 1. The woman underwent radiation therapy and, on physical examination at 1 and 6 months and 1 year following treatment, she had no palpable residual mass, skin erythema or swelling, and no range of motion deficits. An MRI of her right arm, conducted 6 months after treatment, showed no residual disease. Author comment: Whether or not our patient's triceps MALT was coincidental or related to her influenza vaccinations remains undetermined." The patient's outcome was not reported. Documents held by sender: None.
Age: 67.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Biopsy muscle abnormal, Extranodal marginal zone B-cell lymphoma (MALT type) stage I, Immunohistochemistry, Injection site mass, Injection site pain
Clinical narrative: Initial report was received from the scientific literature on 25 June 2012. The following is verbatim from the report: "A 67-year-old woman developed a MALT lymphoma in the same area that she had previously received an influenza virus vaccine injection. The woman received an influenza virus vaccination (dosage not stated) in her right arm and, 1 month later, she developed pain and a lump at the same site. Initially, she was thought to have a torn triceps muscle but a subsequent MRI of her right upper arm revealed a 4.3 x 1.1 x 7.5cm enhancing mass in the posterolateral region of the long head of the right triceps muscle. A core biopsy showed small B-cell type low grade lymphoma and an incisional biopsy showed B-cell-type lymphoma infiltrating the skeletal muscle. Immunohistochemical staining was consistent with marginal zone lymphoma. She was staged 1 E and was given an International Prognostic Index score of 1. The woman underwent radiation therapy and, on physical examination at 1 and 6 months and 1 year following treatment, she had no palpable residual mass, skin erythema or swelling, and no range of motion deficits. An MRI of her right arm, conducted 6 months after treatment, showed no residual disease. Author comment: Whether or not our patient's triceps MALT was coincidental or related to her influenza vaccinations remains undetermined." The patient's outcome was not reported. Documents held by sender: None.
Age: 67.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Muscle mass, Nuclear magnetic resonance imaging abnormal, Radiotherapy
Clinical narrative: Initial report was received from the scientific literature on 25 June 2012. The following is verbatim from the report: "A 67-year-old woman developed a MALT lymphoma in the same area that she had previously received an influenza virus vaccine injection. The woman received an influenza virus vaccination (dosage not stated) in her right arm and, 1 month later, she developed pain and a lump at the same site. Initially, she was thought to have a torn triceps muscle but a subsequent MRI of her right upper arm revealed a 4.3 x 1.1 x 7.5cm enhancing mass in the posterolateral region of the long head of the right triceps muscle. A core biopsy showed small B-cell type low grade lymphoma and an incisional biopsy showed B-cell-type lymphoma infiltrating the skeletal muscle. Immunohistochemical staining was consistent with marginal zone lymphoma. She was staged 1 E and was given an International Prognostic Index score of 1. The woman underwent radiation therapy and, on physical examination at 1 and 6 months and 1 year following treatment, she had no palpable residual mass, skin erythema or swelling, and no range of motion deficits. An MRI of her right arm, conducted 6 months after treatment, showed no residual disease. Author comment: Whether or not our patient's triceps MALT was coincidental or related to her influenza vaccinations remains undetermined." The patient's outcome was not reported. Documents held by sender: None.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Shingles despite never having had chicken pox.
Age: 39.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blister, Lymphadenopathy, Pyrexia
Clinical narrative: 6/22/12 - noticed 2 small clear vesicles on (L) wrist - continued to have several more over next 2 weeks. 7/7/12 developed fever, swollen lymph nodes. No fever today. Note: also had MMR on 6/22/12.
Age: 34.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Axillary pain, Erythema, Injection site erythema, Injection site pain, Lymphadenitis
Clinical narrative: Pt. experienced pain, redness at injection site radiating to right axilla which progressively got worse. Presented to ER on 7/4/12 - Dx: Lymphadenitis. Rx: BACTRIM, KEFLEX, Hydrocodone.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Convulsion, Gaze palsy, Pyrexia, Tonic clonic movements
Clinical narrative: Pt went to ED with afebrile seizure - eyes rolled back, tonic-clonic movement of arms x 10 mins. That night fever elevated to 100.4 while in hospital.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Fever 105, febrile seizure.
Age: 0.3
Sex: F
Vaccine: DTAP, PNC13, RV1
Symptoms: Laboratory test normal, Petechiae
Clinical narrative: This is a spontaneous report from a contactable physician through a Pfizer sales representative. A 4-months-old female patient received PREVENAR 13, INFANRIX and ROTARIX, via an unspecified route of administration on unknown date. The patient medical history and the concomitant medications were not reported. The patient received the first dose of PREVENAR 13 on 30Apr2012. After the second vaccination on 29May2012 the patient experienced petechiae about 12 hours after the injection. The child had been hospitalized for observation and diagnosis but was discharged after 4 days without any findings in lab data. Several time later (unknown date) it was reported that the event petechiae had been recovered.
Age: 0.5
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Pyrexia
Clinical narrative: Initial report was received from a consumer, who was the patient's grandmother, on 28 June 2012. A patient (gender not reported) who was 17-months-old at the time of the report had received a dose three injection of PENTACEL (lot number, route, site and date not reported) at six-months of age. The patient also received doses of PENTACEL at two-months and four-months of age. After the child received the third dose, the patient experienced high fevers to 104.6 degrees Fahrenheit (40.33 degrees Celsius) or 105 degrees Fahrenheit (40.55 degrees Celsius). Ever since then, the child has had high fevers to 104.6 degrees Fahrenheit (40.33 degrees Celsius) or 105 degrees Fahrenheit (40.55 degrees Celsius) every month which last for 4 or 5 days. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: None.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Blister
Clinical narrative: 6/25 Evening of day vaccine administered c/o stomach ache. Cont. with stomach ache but decreased in severity. 6/26 - no diarrhea/vomiting/fever. Blisters started to form bottom lip. 6/27 Blisters increased on bottom lip. Seen by Dr. Continues to have blisters. No fever, no other sx.
Age: 66.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site pain
Clinical narrative: Itch, red, sore at vaccine site.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Gait disturbance, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: Itching followed by swelling and pain over the next 4 days with significant swelling from crease of anterior hip to just distal to patella.  Warmth / pain and antalgic gait noted.
Age: 78.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: REDNESS, SWELLING, ITCHING.
Age: 30.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Activities of daily living impaired, Injection site erythema, Injection site induration, Pain in extremity, Vaccination complication
Clinical narrative: Reported on 6/20/12 that pt. had taken off work 6/15, 6/18 and 6/19 due to sore arms.  Pt. saw private MD on 6/19 with c/o that she had a reaction to immunizations given on 6/14/12.  MD documented that both arms had slight redness and induration at injection site, and gave her work release until 6/25/12.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Dermatitis diaper, Rash erythematous
Clinical narrative: First noticed a diaper rash in the evening of the same day she received vaccinations. It was red with little bumps in the crease of bottom, the creases around her genitals and on her genitals, with a few satellite red bumps around her waist. She is exclusively breast fed and this is the first occurrence of diaper rash. I applied zinc oxide whenever she wore a diaper and tried to leave her without a diaper whenever possible. It cleared up in 3 days.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Huge red hot arm where injection went in. Redness and swelling was 11 cm in diameter and on the fifth day post injection injection site had a darker red hotter center of approx. 6cm with 4-5cm ring on the outer edge of that red and swollen. Very itchy.
Age: 40.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired drug administered
Clinical narrative: Vaccine administered was outdated when given. Expiration date was 7/2/12 and the injection was given 7/5/12.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Marked swelling & redness - entire (L) arm shoulder to elbow within hours of shot some pain. No fever, no SOB, no wheezing.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Angiogram, Blood test, Borrelia test, Ear pruritus, Eye pruritus
Clinical narrative: Information has been received from a 66 year old male patient reporting on himself with seasonal allergy and pain and history of severe back and neck pain who on 03-JAN-2012 was vaccinated with a dose of ZOSTAVAX (Merck) in his left arm (dose, route and lot # not provided). Concomitant therapy included OXYCONTIN and LIPITOR. On approximately 10-JAN-2012 "one week to 10 days later", the patient experienced severe itching of the ears, back, left hip, and crotch on his right side. The itching had gotten progressively worse and worse and the patient stated now event his eyes were itching. The patient stated the itching was worse at night and was usually preceded by tingling. The patient indicated he had been to several health care providers, including Allergist, Neurologist and Dermatologist, and had had numerous tests and labs taken. Laboratory tests included blood labs, thyroid test, Lyme test, CT angiogram, vitamin deficiency test and neurological activity test; results were not provided. The patient was treated with BENADRYL 25 mg and ALLEGRA 180 mg. At the time of the report, the patient had not recovered from the events. The patient stated he had upcoming test schedule: lipid test, CPK test SED rate. Follow-up information from the consumer revealed that since getting the ZOSTAVAX (Merck) his ears continued to itch so badly that he heard a high pitched noise. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Neurological examination, Paraesthesia, Pruritus, Thyroid function test, Tinnitus
Clinical narrative: Information has been received from a 66 year old male patient reporting on himself with seasonal allergy and pain and history of severe back and neck pain who on 03-JAN-2012 was vaccinated with a dose of ZOSTAVAX (Merck) in his left arm (dose, route and lot # not provided). Concomitant therapy included OXYCONTIN and LIPITOR. On approximately 10-JAN-2012 "one week to 10 days later", the patient experienced severe itching of the ears, back, left hip, and crotch on his right side. The itching had gotten progressively worse and worse and the patient stated now event his eyes were itching. The patient stated the itching was worse at night and was usually preceded by tingling. The patient indicated he had been to several health care providers, including Allergist, Neurologist and Dermatologist, and had had numerous tests and labs taken. Laboratory tests included blood labs, thyroid test, Lyme test, CT angiogram, vitamin deficiency test and neurological activity test; results were not provided. The patient was treated with BENADRYL 25 mg and ALLEGRA 180 mg. At the time of the report, the patient had not recovered from the events. The patient stated he had upcoming test schedule: lipid test, CPK test SED rate. Follow-up information from the consumer revealed that since getting the ZOSTAVAX (Merck) his ears continued to itch so badly that he heard a high pitched noise. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Hyperhidrosis, Pyrexia, Tachycardia
Clinical narrative: Fever 99 with 2 ADVIL. Chills, sweats, tachycardia. Symptoms started the evening after the shot was administered and lasted approx 24 hours.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Headache, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a 62 year old female patient with asthma, high blood pressure and no drug reactions/allergies who on 05-JUN-2012 was vaccinated with a dose of ZOSTAVAX (Merck) subcutaneously (dose and lot number not reported). Concomitant therapy included: unspecified "asthma medication" and unspecified "high blood pressure medication". It has been reported that on 06-JUN-2012 the patient had large, hot, swollen left arm, along with headaches since the ZOSTAVAX (Merck) was administered. There was no treatment given for an AE. At the time of the report the patient's outcome was unknown. The patient did not seek medical attention. No laboratory/diagnostic studies were performed. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left arm injection site swelling, redness, hot to touch and pain. Nausea - HA. Resolved after 2 days. (1 inch needle used)
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea
Clinical narrative: Left arm injection site swelling, redness, hot to touch and pain. Nausea - HA. Resolved after 2 days. (1 inch needle used)
Age: 31.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during breast feeding, No adverse event
Clinical narrative: Information has been received from a physician concerning a 31 year old female patient who was breastfeeding an infant and who on unknown date was vaccinated with a dose of GARDASIL (dose, route and lot number not reported). No adverse effects were reported. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary mass, Injection site swelling, Oedema peripheral, Pain
Clinical narrative: Swelling left arm and a lump under her axilla c/o of pain. 1 inch needle used. Half of upper arm was swollen. Came to clinic on 6/12 and back on 6/18 with pain and decreased swelling, lump still present.
Sex: F
Vaccine: HPV4
Symptoms: Ovarian cyst
Clinical narrative: Information has been received from a consumer concerning female patients who on unknown dates were vaccinated with a dose of GARDASIL (doses, routes and lot numbers not reported). Subsequently, on an unknown date, those patients experienced ovarian cysts. At the time of the report the patients' outcomes were unknown. It was unspecified if the patient's sought medical attention. This is one of several reports received from the same source. Attempts are being made to obtain additional 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. This is an amended report. The therapy start date and concomitant therapy were detected as they were incorrectly entered.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red and mildly swollen (Tdap only).
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a registered pharmacist concerning a 67 year old female patient who on 23-JUN-2012 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) subcutaneously in the right arm (lot number not reported). The pharmacist reported that a "couple days ago" the patient showed her a small area at the right arm injection site, that was red, puffy and itchy. The pharmacist confirmed that the patient did not have a rash. BENADRYL oral was given as a treatment for the experience. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV2, HPV2
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 15.0
Sex: F
Vaccine: HPV2, HPV2
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Nausea
Clinical narrative: None stated.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Injection site pruritus, Injection site swelling, Pyrexia, Rash
Clinical narrative: Injection given (PNEUMOVAX) 7/7/12 at 12:50 pm. (L) deltoid. Upper (L) arm swollen with itchy at site, febrile, fatigue. Rash on Sunday. Monday feeling better. Rash resolved, fever gone.
Age: 1.11
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Aspiration, Choking, Death, Respiratory arrest, Vomiting
Clinical narrative: Initial report was received on 12 October 2011 from an investigator participating in the study under the reference number M5A11. A 17 month-old female patient with no reported past medical history experienced respiratory arrest due to aspiration (resulting from vomiting) 123 days after receiving dose four of PENTACEL, lot number C3747AB (route and site of administration not reported) on 27 April 2011. Additional vaccine history included a first dose of MMR, lot number 1644Z (route and site of administration not reported) received on 01 July 2011. According to the investigator, a representative from the coroner's office was told that the "child likely choked on a ravioli as fed by a parent". No autopsy was performed as it was not a coroner's case. The outcome was fatal. According to the investigator, the event was not related to the trial product. Documents held by sender: none.
Age: 1.29
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Blister, Convulsion, Febrile convulsion, Pyrexia, Rash
Clinical narrative: 7 days after vaccines given patient started having fevers. He may have had a few "spots" on skin per mom. The next day he had a seizure - seen in ER. Dx with his 1st febrile sz. The next day he started having an itchy rash consisting of red papules and few with vesicles. I saw him on day 4 of illness or 10 d post-vaccine. Fever is still ongoing. Rash mostly on trunk but does involve scalp and extremities.
Age: 1.29
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Rash papular, Rash pruritic
Clinical narrative: 7 days after vaccines given patient started having fevers. He may have had a few "spots" on skin per mom. The next day he had a seizure - seen in ER. Dx with his 1st febrile sz. The next day he started having an itchy rash consisting of red papules and few with vesicles. I saw him on day 4 of illness or 10 d post-vaccine. Fever is still ongoing. Rash mostly on trunk but does involve scalp and extremities.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Adverse reaction, Arthralgia, Injection site pain, Injection site swelling
Clinical narrative: Injection site swollen, sore, complained of joints aching/pain, urgent care told parent that it was a adverse reaction.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Radiculitis brachial
Clinical narrative: Her physician called to say she has a brachial neuritis 10 days later.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Dry skin, Exfoliative rash, Herpes zoster, Rash
Clinical narrative: Within two days after receiving vaccine patient developed a rash which was rough & scaly in appearance. Patient said it was itchy & burning. It was located on her arm, face, & back, but not around the injection site. The doctor diagnosed it as shingles & treated it as such with antivirals & pain medicine. On follow up with patient rash is not on entire face, both legs, & across chest. Patient going back to doctor.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Within two days after receiving vaccine patient developed a rash which was rough & scaly in appearance. Patient said it was itchy & burning. It was located on her arm, face, & back, but not around the injection site. The doctor diagnosed it as shingles & treated it as such with antivirals & pain medicine. On follow up with patient rash is not on entire face, both legs, & across chest. Patient going back to doctor.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Patient presented on 6/25/12, with complaints of arm pain after receiving ZOSTAVAX injection 6/21/12. The area was red and warm to the touch. The red area was spreading, itching, and painful, treated with Antibx, ALLEGRA and cold packs.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Vasovagal syncope, prolonged episode, required IV fluids in ER.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site discomfort, Injection site erythema
Clinical narrative: Redness & discomfort to (rt) deltoid. Ice pack placed. Patient treated with KEFLEX 250 mg/5mL 2 tsp. TIX x10d.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Fever, body aches, axillary lymphadenopathy (2 days).
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Dizziness, Fall, Hyperhidrosis, Pyrexia
Clinical narrative: Pt presented to ED, 2 - 3 days after receiving a PNEUMOVAX shot at her physician's office. Chills. fever, lightheaded, dizzy, sweating & fell. Pt given IV fluids & monitoring. Later sent home w/daughter.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Nodule, Pain in extremity, Skin warm, Urticaria
Clinical narrative: Pain in arm, warm to touch, red, feels a knot, & hives.
Age: 16.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Slight swelling & redness dev Fri after vaccine. Increased swelling & soreness Sat & Sun.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Rec'd ZOSTAVAX on 6/26/12 - following day 6/27/12 woke up with red swollen area above (L) eye - no itching - followed up with primary physician.
Age: 26.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Urticaria
Clinical narrative: Patient states that, 24 hrs. after she had the varicella injection in her right arm, she developed large skin reddening about 70 mm in size with a dime size wheal. The next day it gradually waned and signs & symptoms disappeared on the 3rd day. She experienced no itching and generalized symptoms.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Erythema, Local swelling, Nasal congestion, Sinus congestion
Clinical narrative: Began with red spot just below injection site. (Raised & hot). Then stuffy nose & head. Dry cough. Patient treated symptoms w/OTC medications.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Began with red spot just below injection site. (Raised & hot). Then stuffy nose & head. Dry cough. Patient treated symptoms w/OTC medications.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 6/8/12 Patient said he had a redness & swelling at the injection site. I let him know that it is a mild side effect after getting the ZOSTAVAX shot. He went to the doctor and they gave him cephalexin on 6/9/12.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Paraesthesia oral
Clinical narrative: Erythema, induration at the site of injection with warmth and pain. She did have tingling in her tongue for a few hours. Antibiotics given.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abnormal behaviour, Decreased appetite, Emotional distress, Erythema, Screaming
Clinical narrative: Shots around 2 pm. Intermittently inconsolable for 10 hours. Red, screaming, shreaking, kicking arms and legs. "Would not breast feed well." Totally not acting himself.: TYLENOL did not help. (Started at 5 pm).
Age: 33.0
Sex: M
Vaccine: TYP, YF
Symptoms: Oropharyngeal pain, Pyrexia, Rash
Clinical narrative: Pt presented to clinic 7/9/12 c/o getting a rash to face - head - hands & under bottom of feet - Sore throat and fever of 102 degrees about 48 hours after getting yellow fever & Typhoid vaccine.
Age: 11.0
Sex: M
Vaccine: HEP, HPV4, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Redness and swelling on left arm-treatment per urgent care-antibiotics given in case of infection.
Age: 41.0
Sex: M
Vaccine: HEPA, TDAP, TYP, YF
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash on hands and feet.  Itchy.  "Looks like hives" per patient.  No SOB, swelling, DIB, CP.
Age: 2.0
Sex: M
Vaccine: HEP, HEPA, VARCEL
Symptoms: Papule, Rash
Clinical narrative: Developed papules on face and trunk, and continued to get more bumps for 5 days.  No other signs of illness.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HPV4, MMR, VARCEL
Symptoms: Accidental exposure, No adverse event
Clinical narrative: Patient was given HPV vaccine inadvertently. NP notified, patient examined upon discovery, no adverse signs or symptoms.
Age: 1.13
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Received VARIVAX 6/8/12. Admitted to medical center 6/26/12 with mult issues, including varicella-like vesicular rash scattered on body (begun about 5 days prior).
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal discomfort, Abdominal pain, Asthenia, Constipation, Headache
Clinical narrative: Constant complaint of stomach problems, headaches, menstrual cycle totally off, severe abdominal pain, constipation, lethargic, sharp mood swings, no energy.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Lethargy, Menstruation irregular, Mood swings
Clinical narrative: Constant complaint of stomach problems, headaches, menstrual cycle totally off, severe abdominal pain, constipation, lethargic, sharp mood swings, no energy.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Erythema, Headache, Herpes zoster, Injection site pain
Clinical narrative: Noted "rough patch" on skin while washing her back in the shower. Rough patch is at left lower back to left of midline. Also noted bilateral pedal edema. 7/8 and 9 has headache, generalized body aches "like a virus", bilateral pedal edema persists but improved, original "rough patch" persists but less red, site stings and itches. 7/9 Had an appointment with her oncologist (well check) he agrees with patient that it is shingles.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Oedema peripheral, Pain
Clinical narrative: Noted "rough patch" on skin while washing her back in the shower. Rough patch is at left lower back to left of midline. Also noted bilateral pedal edema. 7/8 and 9 has headache, generalized body aches "like a virus", bilateral pedal edema persists but improved, original "rough patch" persists but less red, site stings and itches. 7/9 Had an appointment with her oncologist (well check) he agrees with patient that it is shingles.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash vesicular
Clinical narrative: Information has been received from a pharmacist concerning a female who was vaccinated with 0.65 ml dose of ZOSTAVAX (Merck) while she had an active case of shingles and got a rash at the injection site that looked like shingles. It was unknown if the patient sought medical attention. At the time of report, the patient's status was unknown. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Pt has a red, swollen area on (L) arm measuring 11 cm x 15 cm, pt describes as "itchy".
Age: 78.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a registered pharmacist concerning a 78 year old patient who "today" on 29-JUN-2012, was vaccinated with a dose of ZOSTAVAX (Merck) (lot number 664444/0722Y) that was expired (dose and route not reported). The vaccine expired on 21-NOV-2010. No adverse effects were reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Lymphadenopathy, Oedema peripheral, Vaccination site pain, Vaccination site swelling
Clinical narrative: MENACTRA vaccine received 6/29/2012. Dr. was paged on call 6/30 by mother. Vaccine site sore, red & swollen, armpit felt swollen, like lymph node swollen. Mother giving MOTRIN 400 every 4 hours. Dr. recommended adding BENADRYL & heating pad & if not improving to urgent care or ER.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: Urticarial rash.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacist concerning a 79 year old male with drug allergies to RISPERDAL and LOVENOX who on 28-JUN-2012 was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (Lot# not reported). On 28-JUN-2012 the patient developed rash after receiving PNEUMOVAX 23. The patient saw physician to seek medical attention. No treatment was given. At the time of this report, the status of the patient was not known. No further information is available.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a pharmacist concerning a 52 year old female patient who on an unspecified date was vaccinated SC with single 0.65ml dose of ZOSTAVAX (Merck). Subsequently the patient had a small bump or rash at the injection site. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a female patient with type 1 diabetes and spinal disc problem who in approximately March, 1997 ("about 15 months of age") and in 2008, was vaccinated with the first and second dose of VARIVAX (Merck), respectively. Concomitant therapy included corticosteroids (unspecified). The physician reported that since vaccination with VARIVAX (Merck) the patient had had 3-4 cases of shingles. The most recent case was in approximately 22-JUN-2012 ("about 1 week ago"). At that time she had a steroid injection for a spinal disc problem and then developed shingles. The lesions were on her lower back and upper buttocks. The patient had bee seen by physician for medical attention. ZOVIRAX was given for most recent case of shingles. At the time of the report, the patient's shingles persisted. HCP was interested in VZV Analysis by PCR (Polymerase Chain Reaction) and wanted to send viral isolates. VZID packet faxed. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a physician assistant concerning a patient who on approximately 25-JUN-2012 (reported as "within a week") was vaccinated IM with a dose of MMR II, 0.5ml, which expired in April 2012. No adverse event reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Headache, Pyrexia, Rash erythematous, Rash papular
Clinical narrative: Patient developed headache and joint pain (elbow, knees, shoulders) as well as fever 1 day after vaccination. Tmax 100.5 patient also developed rash, papular, erythematous scattered to face, arms and chest area 5 days after vaccination. Non pruritic.
Age: 16.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Head injury, Syncope
Clinical narrative: Patient suddenly became dizzy & fainted hitting her head on the desk and floor.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Large reddened area at site of vaccination, 150mm x 150mm, rechecked area 1 day after 120mm x 100mm with MOTRIN/cool compresses.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, RV1, RV1
Symptoms: Intestinal obstruction, Intussusception
Clinical narrative: Intussusception with bowel obstruction.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, RV1, RV1
Symptoms: Crying, Gastritis, Haematochezia, Intestinal obstruction, Intussusception
Clinical narrative: Intussusception with bowel obstruction.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, RV1, RV1
Symptoms: Irritability, Surgery, Vomiting, X-ray abnormal
Clinical narrative: Intussusception with bowel obstruction.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, RV1, RV1
Symptoms: Intussusception
Clinical narrative: Intussusception with bowel obstruction.
Age: 25.0
Sex: M
Vaccine: VARCEL
Symptoms: Angioedema, Rash pruritic, Urticaria
Clinical narrative: Pt had angioedema and rash (pruritic) on face - hives - required ER visit.
Age: 64.0
Sex: F
Vaccine: HEPA, PPV, TYP
Symptoms: Injection site swelling, Oedema peripheral, Rash macular
Clinical narrative: Pt returned to clinic 7-2-12. Pt states (L) arm began to swell above elbow down to lower arm - pt does not recall exact time or day only that she noted it while taking a shower. Pt. did ice the area stating it becomes worse when taking warm showers. Pt did not state it was painful only swollen & blotchy, no red. Pt reminded to go see her PMD if it remains a concern.