chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HPV2
Symptoms: Arthralgia, Dyspnoea, Headache, Nausea, Pruritus
Clinical narrative: Joint pain, headache, nausea, difficulty breathing & very itchy.
Age: 6.0
Sex: M
Vaccine: PPV
Symptoms: Blood culture, Cellulitis, Full blood count, Injected limb mobility decreased, Injection site erythema
Clinical narrative: Fever, rash. On 3/20/13 area of injection red & painful, was extending from (L) upper arm to elbow with warmth, redness & swelling. Refusing to move arm. Hospitalized & started on antibiotics for cellulitis possibly x 36 hours. Discharged 3/22/13.
Age: 6.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Nuclear magnetic resonance imaging, Pyrexia
Clinical narrative: Fever, rash. On 3/20/13 area of injection red & painful, was extending from (L) upper arm to elbow with warmth, redness & swelling. Refusing to move arm. Hospitalized & started on antibiotics for cellulitis possibly x 36 hours. Discharged 3/22/13.
Age: 6.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Fever, rash. On 3/20/13 area of injection red & painful, was extending from (L) upper arm to elbow with warmth, redness & swelling. Refusing to move arm. Hospitalized & started on antibiotics for cellulitis possibly x 36 hours. Discharged 3/22/13.
Age: 6.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness and warmth of injection site went to ER on 03/20/12 then f/u with PMD on 03/21/12.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Dyskinesia, Electroencephalogram abnormal, Excessive eye blinking, Grimacing, Myoclonic epilepsy
Clinical narrative: This case was reported by a consumer (subject's mother) and described the occurrence of myoclonic seizure nos in a 2-year-old male subject who was vaccinated with Hepatitis A vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medications included Anesthesia for the MRI (magnetic resonance imaging) test on 7 March 2013. On 16 January 2013 at 14:30 the subject received a dose of Hepatitis A vaccine (unknown route and volume, unknown thigh). The reporter stated that the vaccine was administered on 16 January 2013 or 23 January 2013. It was unclear at the time of reporting why the dates were unclear. On 19 January 2013 (or 26 January 2013 dependant on the date of vaccine administration), 3 days after vaccination with Hepatitis A vaccine, the subject experienced jerking of head ("jerking his head backwards in a strange manner"), grimacing ("grimacing his face further clarified as scrunching up eye and nose area") and repetitive eye blinking ("blink his eyes non-stop"). The reporter stated that these events "started off slowly but by the following weekend, it had worsened." The mother reported that the subject was having "50 episodes of these a day but later slowed to about 30 times a day." The subject was hospitalised; however, the dates of hospitalisation were not reported. Relevant test results included an outpatient MRI on 7 March 2013, specific results not reported, and EEG (electroencephalogram) on 8 March 2013, specific results not reported. Based on the results of the MRI and EEG, the subject was "formally diagnosed as having myoclonic seizures" on 8 March 2013. The subject was treated with DEPAKOTE which began on 8 March 2013. Per the reporter, the events had improved "but the dosage might need to be further adjusted." At the time of reporting the events were improved. The mother stated that the subject's "physician reported these events to VAERS but did not think the seizures were related to the hepatitis A vaccine." It was unknown if the immunization series was discontinued or delayed at the time of reporting. The mother also reported another case. See case A 1017132A for details on the other case.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Nuclear magnetic resonance imaging abnormal
Clinical narrative: This case was reported by a consumer (subject's mother) and described the occurrence of myoclonic seizure nos in a 2-year-old male subject who was vaccinated with Hepatitis A vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medications included Anesthesia for the MRI (magnetic resonance imaging) test on 7 March 2013. On 16 January 2013 at 14:30 the subject received a dose of Hepatitis A vaccine (unknown route and volume, unknown thigh). The reporter stated that the vaccine was administered on 16 January 2013 or 23 January 2013. It was unclear at the time of reporting why the dates were unclear. On 19 January 2013 (or 26 January 2013 dependant on the date of vaccine administration), 3 days after vaccination with Hepatitis A vaccine, the subject experienced jerking of head ("jerking his head backwards in a strange manner"), grimacing ("grimacing his face further clarified as scrunching up eye and nose area") and repetitive eye blinking ("blink his eyes non-stop"). The reporter stated that these events "started off slowly but by the following weekend, it had worsened." The mother reported that the subject was having "50 episodes of these a day but later slowed to about 30 times a day." The subject was hospitalised; however, the dates of hospitalisation were not reported. Relevant test results included an outpatient MRI on 7 March 2013, specific results not reported, and EEG (electroencephalogram) on 8 March 2013, specific results not reported. Based on the results of the MRI and EEG, the subject was "formally diagnosed as having myoclonic seizures" on 8 March 2013. The subject was treated with DEPAKOTE which began on 8 March 2013. Per the reporter, the events had improved "but the dosage might need to be further adjusted." At the time of reporting the events were improved. The mother stated that the subject's "physician reported these events to VAERS but did not think the seizures were related to the hepatitis A vaccine." It was unknown if the immunization series was discontinued or delayed at the time of reporting. The mother also reported another case. See case A 1017132A for details on the other case.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthropod bite, Erythema, Induration, Injection site reaction, Local swelling
Clinical narrative: Receive SQ injection in left upper arm on 3/24/2013 reported noticing reaction to site of injection 3/26/2013: dark red raised area an inch in diameter with diffuse pink ring was hard and painful.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site induration, Injection site pruritus
Clinical narrative: Inj. site became hard and itchy after 48 hours difficult to move arm in 72 hours. Patient treated with ibuprofen and warm compress. Much improved after 4 days.
Age: 19.0
Sex: M
Vaccine: ADEN_4_7, FLU3, IPV, MNQ, TDAP
Symptoms: CSF protein increased, Cough, Electromyogram abnormal, Epstein-Barr virus antibody positive, Immunoglobulin therapy
Clinical narrative: Sx began with bil calf pain, admitted on 30-31 Jan and assessed with viral myositis. Sx increased, now with upper extremity weakness, readmitted 06 Feb; pos EMG findings, Increased CSF protein. Received IVIG x4 with Improvement. Assessed with monophasic polyneuropathy with complete recovery by 05 Mar 13.
Age: 19.0
Sex: M
Vaccine: ADEN_4_7, FLU3, IPV, MNQ, TDAP
Symptoms: Laboratory test normal, Muscular weakness, Oropharyngeal pain, Pain in extremity, Polyneuropathy
Clinical narrative: Sx began with bil calf pain, admitted on 30-31 Jan and assessed with viral myositis. Sx increased, now with upper extremity weakness, readmitted 06 Feb; pos EMG findings, Increased CSF protein. Received IVIG x4 with Improvement. Assessed with monophasic polyneuropathy with complete recovery by 05 Mar 13.
Age: 19.0
Sex: M
Vaccine: ADEN_4_7, FLU3, IPV, MNQ, TDAP
Symptoms: Rhinorrhoea, Viral myositis
Clinical narrative: Sx began with bil calf pain, admitted on 30-31 Jan and assessed with viral myositis. Sx increased, now with upper extremity weakness, readmitted 06 Feb; pos EMG findings, Increased CSF protein. Received IVIG x4 with Improvement. Assessed with monophasic polyneuropathy with complete recovery by 05 Mar 13.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, FLU3, RV5
Symptoms: Abdominal mass, Haematochezia, Intestinal operation, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: 6 mth old male with Trisomy 21 received Rotavirus vaccine 11-27-12, developed blood in stool 12-03-12. Abdominal US showed intussusception. Attempted laparoscopic repair converted to open reduction. Discharge home after 2 days.
Age: 1.75
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: Crying, Pyrexia, Screaming
Clinical narrative: 1. Woke up screaming, crying x 2 in night. 2. Fever of 101 F temporal at 8 am on 3/27/2013.
Age: 25.0
Sex: F
Vaccine: TD, TYP, YF
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Stated itching on right side of neck, shoulder and back at 5:00 PM. It then moved quickly to full body. Took 50mgs of Benadryl. On 3/26/2013, took another 50mgs of Benadryl, this time it didn't work. Hives started on both sides of neck under ears. Called doctor at 10 AM and got 6mgs of Decadron. Helped itching a little bit and hives went away. Went to the Emergency Room at 4 AM 3/27/2013 because of itching on the tongue in addition to itching head to toe. Was administered DexaMETHAsone Phos inj at 20mgs. Was prescribed Pepcid and Prelone and am to take both twice a day for 5 days. Was told to go to doctor if not better by 3/28/2013 or 3/29/2013.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Pruritus, Rash, Swelling
Clinical narrative: Within 2 weeks after receiving HPV4, child developed two areas of rash (raised: one dime size and one quarter size.  Located under L arm towards back and one left back near waist.  Parent said outside ring was raised and then inside became raised; itchy; no vesicles; no resp involvement; no lip swelling; not sick at time.  Used OTC ringworm med thinking it was that.  Didn't help but self resolved within 2 weeks.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site ulcer, Local reaction
Clinical narrative: Local reaction at injection site, created a quarter sized open wound sore. Involved deteriorating tissue surrounded by bright red tissue.  Small amount of itching noted.  Doctor prescribed SSD cream and Cephalexin on 3/8/13, cephalexin continued on 3/21/13.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Eye swelling, Rash, Visual impairment
Clinical narrative: Approx. 7-10 days after vaccine patient noticed a rash around corner of mouth and R eye swelling.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Balance disorder, Blister, Chest pain, Dyspnoea, Eyelid oedema
Clinical narrative: Approx. 7-10 days after vaccine patient noticed a rash around corner of mouth and R eye swelling.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Oral mucosal blistering, Pericarditis, Rash, Swelling face
Clinical narrative: Approx. 7-10 days after vaccine patient noticed a rash around corner of mouth and R eye swelling.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Rash on arm.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Red, warm induration at injection site.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Eye swelling, Lip swelling, Urticaria
Clinical narrative: First had nonproductive cough couple days after vaccine then broke out in full body hives with swelling of lips and eyes about 6 days after receiving the vaccine.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: Vaccination area was swollen, red and felt hard to the touch.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: He thinks he scratched the vaccine.  He went to the ER.
Age: 12.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Erythema, Rash generalised, Urticaria
Clinical narrative: Mom called day after vaccination, stated pt. had HPV and flu shot yesterday.  Went to schoool today, school nurse called mom to get him, had rash all over.  When she saw him, he had hives all over his body, looked beet red.  No lip swelling, or shortness of breath.  She gave him 25mg. of Benadryl. Nurse advised to give another 25mg, pt improved, but had flare ups of hives all over body for next two to three days requiring hydroxyzine, before resolving. Did not require any other therapy or physician visits. Parents and physician agreed he will not get the HPV again.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HEP, PPV, RVX
Symptoms: Pyrexia, Rash
Clinical narrative: Fever of 102.4, later followed by rash that has gotten worse over last 2 months.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Feeling abnormal, Gait disturbance
Clinical narrative: Arrived at motel for vacation Thanksgiving and had issues walking to room. Felt very weak and never felt right. Cut short five day stay and went home. Thought it was touch of flu and continued pre-planned travel thinking she'd feel better.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to unspecified patients of unknown ages and gender. On an unknown date unspecified patients received second dose of GARDASIL (dose, indication and route of administration were not reported) (lot number unspecified) late, beyond the recommended two months. Concomitant medications were not reported. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 19 year old patient (gender not specified). On 14-MAR-2013 the adult patient was vaccinated with a pediatric booster dose of VAQTA dose 1, (0.5 ml, intramuscular). On 16-MAR-2013 the patient received a second dose of pediatric VAQTA. Lot no. information was not provided. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a physician refers to a female patient of unknown age. No medical history was reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose, route not reported) at an unspecified pharmacy and the patient questioned the storage of the ZSOTAVAX at the time she received the vaccine. No concomitant medications were reported. The patient stated she did not feel that the storage of the vaccine was "adequate". No known temperature conditions can be verified as the patient just felt it was not stored properly. Additional information is not expected.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Contusion, Idiopathic thrombocytopenic purpura
Clinical narrative: This spontaneous report was received from a physician via company representative concerning a 17 year old (at the time of event) (also reported as 18 year old at the time of reporting) patient of unknown gender. On 03-OCT-2012, the patient was vaccinated with single dose of GARDASIL (lot number, expiry date, dose and route unspecified). However it was unspecified if this dose constituted the first, second or third dose for the patient. No concomitant medications were reported. On 12-OCT-2012, the patient developed bruising and idiopathic thrombocytopenic purpura (ITP). It was unspecified if the patient sought any medical attention. The patient was referred to a hematologist however no follow up was taken place. It was unspecified if the patient was treated or if any lab tests were performed. The outcome of the events were unknown. The relatedness for the events was unknown for GARDASIL. Upon internal review, the event idiopathic thrombocytopenic purpura (ITP) was considered as medically significant. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Ageusia, Headache, Hypoaesthesia, Musculoskeletal stiffness, Neck pain
Clinical narrative: A "Bells-Palsy"-like symptoms: numbness, tingling, ringing in ears, taste sensation lost, headache/neck pain stiffness. Dropping on right side of face.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Paraesthesia, Tinnitus, VIIth nerve paralysis
Clinical narrative: A "Bells-Palsy"-like symptoms: numbness, tingling, ringing in ears, taste sensation lost, headache/neck pain stiffness. Dropping on right side of face.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Activities of daily living impaired, Eyelid function disorder, Hypoaesthesia, VIIth nerve paralysis
Clinical narrative: A "Bells-Palsy"-like symptoms: numbness, tingling, ringing in ears, taste sensation lost, headache/neck pain stiffness. Dropping on right side of face.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Eyelid function disorder, Headache, Hypoaesthesia, VIIth nerve paralysis
Clinical narrative: A "Bells-Palsy"-like symptoms: numbness, tingling, ringing in ears, taste sensation lost, headache/neck pain stiffness. Dropping on right side of face.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, redness and itching right deltoid at site of injection. Use OTC BENADRYL.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Myalgia
Clinical narrative: Feels muscle pain at site of injection.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Cold sweat, Nausea, Pyrexia, Salivary hypersecretion
Clinical narrative: Patient received shot 4pm- had chinese food then at 11pm started having nausea, cold sweats and severe salivating continued until next day. Also fever. Recovered in 2 days.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: Pt. reported this today for 1st time - came in for Hep B #3 today and stated after both doses #1 and #2 of Hep B, developed itching and hives within 3-4 hours - on both arms only. Did not seek treatment or do anything and both times the itching and hives resolved within a few more hours. Before getting final dose, pt advised to have titer done or see allergist.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Electroencephalogram normal, Eye movement disorder, Irritability
Clinical narrative: Developed fussiness, stereotypical eye movements the day of immunizations, was admitted to hospital to rule out seizures on 3/21/13; EEG nl, no specific encephalopathy. No evidence of additional neuro symptoms.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 25-AUG-2012 the patient was vaccinated with VAQTA dose 1 (lot number, expiration date, concentration and route of administration were not reported) and one month after, on 25-SEP-2012 the patient received dose number 2 (lot number, expiration date, concentration and route of administration were not reported). The patient didn't experienced any adverse event, however the vaccine was administered in an inappropriate schedule. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Amnesia
Clinical narrative: Information has been received from a physician concerning a female patient who on unspecified date was vaccinated with a dose of GARDASIL (Lot #, dose and route not reported). The physician reported that the patient was on GARDASIL regimen and experienced memory loss. The patient was working with their healthcare provider to address the situation. At the time of the report the patient's outcome was unknown. It has been determined that case #1203USA02733 is duplicate of case #1203USA02625. Therefore, case #1203USA02733 is being deleted from our files and the cases consolidated into case #1203USA02625. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash, Local reaction, Local swelling
Clinical narrative: This spontaneous report as received from a physician refers to one of 1 year old male twin infants. On an unknown date the patient was vaccinated with the first dose of (Merck) VARIVAX (Lot# not reported). On an unknown date both of the twin infants developed a raised area and local reaction rash at the injection site. The outcome was unknown. The patient sought medical attention through seeing the physician. This is one of two reports received from the same reporter. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, PPV, TDAP
Symptoms: Face injury, Fall, Suture insertion, Syncope
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative refers to a 15 year old female patient. "Within the last few weeks", in approximately 2013 the patient was vaccinated with GARDASIL (lot # not reported), accompanied with PNEUMOVAX23 (lot # not reported) and Dtap vaccines (unspecified manufacturer) simultaneously. The patient experienced syncope and within minutes fell and bumped her chin, which required stitches. This was completed in the office. The outcome was unknown. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient with hypertension. On 07-MAR-2013 the patient was vaccinated with ZOSTAVAX (lot # H016762, expired date 11-DEC-2013) (dose, route and indication were not reported) in the arm. Several days ago, in March 2013 the patient experienced an injection site reaction with itching on the back of arm in which she received the vaccination and the reporter described the rash as faint and "speckly". There was no vesicles. The action taken, outcome and causality were not provided. The patient had contacted pharmacist for medical attention. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash, Local reaction, Local swelling, Rash
Clinical narrative: This spontaneous report as received from a physician refers to one of 1 year old male twin infants. On an unknown date the patient was vaccinated with the first dose of VARIVAX (Merck) (Lot # not reported). On an unknown date both of the twin infants developed a raised area and local reaction rash at the injection site. The patient also had the rash over his legs and arms. The outcome was unknown. The patient sought medical attention through seeing the physician. This is one of two reports received from the same reporter. Additional information is not expected.
Age: 60.0
Sex: M
Vaccine: HEPAB, VARZOS
Symptoms: Pruritus, Rash, Varicella
Clinical narrative: This spontaneous report as received from Nurse practitioner regarding a 60 years old male patient with no pertinent medical history and no drug reactions or allergies. On 15-MAR-2013 the patient was vaccinated with ZOSTAVAX 19400 PFU (lot number and expiration date not reported) (dose, route and anatomical site not reported). Other suspect medications included TWINRIX (dose and route not reported). Concomitant therapies included amlodipine besylate, LOTREL. On March 2013 (reported as"this past weekend") the patient came down with rash on his abdomen and on his upper back. Rash was scattered and patient complained of some itching. The Nurse practitioner believed that it was a mild case of Chickenpox. The outcome for the chickenpox was not reported. The reporter stated that no treatment was given for the chickenpox. The patient sought medical attention by going to an office visit. The reporter did not assess the causality between chickenpox and ZOSTAVAX. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: FLU3, MMR, PPV, TDAP
Symptoms: Cellulitis, Erythema, Injected limb mobility decreased, Injection site induration, Injection site nodule
Clinical narrative: Case number PHHY2013US012080 is an initial spontaneous report received from vaccine adverse event reporting system website (VAERS reference number: 475048) on 08 Feb 2013 with a follow up information received from the quality assurance department (reference number: 211917) on 21 Mar 2013. This case refers to a 30-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1207101) in her left arm on 15 Oct 2012. On the same day she was also vaccinated with ADACEL (other manufacturer, batch number: U4421AA) in her left arm, PNEUMOVAX (other manufacturer, batch number: H010515) in her right arm, and MMR II (other manufacturer, batch number: 0367AE) subcutaneously in her right arm. On 16 Oct 2012, within one day she developed small red rash in left arm which started spreading, making it difficult to move arm. Her left arm became swollen, red, hot and tender. On 17 Oct 2012 she visited her primary care physician and was diagnosed with cellulitis. She received antibiotics (not specified) as treatment. As of 23 Oct 2012 she had hard knot at the injection site. On an unspecified date she had recovered completely. The seriousness and causality were not reported. The quality assurance department opened a complaint with reference number 211917. Based on the documents review performed, it was stated that the FLUVIRIN batch 1207101 was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No other information was available. Follow up information received from the quality assurance department on 21 Mar 2013: Batch summary updated.
Age: 30.0
Sex: F
Vaccine: FLU3, MMR, PPV, TDAP
Symptoms: Oedema peripheral, Rash, Rash erythematous, Skin warm, Tenderness
Clinical narrative: Case number PHHY2013US012080 is an initial spontaneous report received from vaccine adverse event reporting system website (VAERS reference number: 475048) on 08 Feb 2013 with a follow up information received from the quality assurance department (reference number: 211917) on 21 Mar 2013. This case refers to a 30-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1207101) in her left arm on 15 Oct 2012. On the same day she was also vaccinated with ADACEL (other manufacturer, batch number: U4421AA) in her left arm, PNEUMOVAX (other manufacturer, batch number: H010515) in her right arm, and MMR II (other manufacturer, batch number: 0367AE) subcutaneously in her right arm. On 16 Oct 2012, within one day she developed small red rash in left arm which started spreading, making it difficult to move arm. Her left arm became swollen, red, hot and tender. On 17 Oct 2012 she visited her primary care physician and was diagnosed with cellulitis. She received antibiotics (not specified) as treatment. As of 23 Oct 2012 she had hard knot at the injection site. On an unspecified date she had recovered completely. The seriousness and causality were not reported. The quality assurance department opened a complaint with reference number 211917. Based on the documents review performed, it was stated that the FLUVIRIN batch 1207101 was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No other information was available. Follow up information received from the quality assurance department on 21 Mar 2013: Batch summary updated.
Age: 61.0
Sex: M
Vaccine: FLU3, PPV, VARZOS
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Case number PHHY2013US012100 is a spontaneous report received initially from vaccine adverse event reporting system website (VAERS reference number: 475076) on 08 Feb 2013, and a follow up received from the quality assurance department (reference number: 211924) on 25 Mar 2013. This case refers to a 61-year-old male patient. His medical history and concomitant medications were not known. He was vaccinated with FLUVIRIN (batch number: 1205301) intramuscularly in his left arm on 18 Nov 2012. On the same day he was also vaccinated with PNEUMOVAX (other manufacturer, batch number: 1706AA) subcutaneously in his left arm and ZOSTAVAX (other manufacturer, batch number: H013017) subcutaneously in his right arm. On 17 Nov 2012 he noticed redness in left arm where the PNEUMOVAX vaccine was administered. On 18 Nov 2012 he went to a clinic to receive antibiotics for cellulitis reaction. On 20 Nov 2012 he came back to the pharmacy because the reaction was not getting better. The final outcome was reported as condition unchanged. The seriousness and causality were not reported. No other information was available. Based on the batch review report it was concluded that the concerned FLUVIRIN batch 1205301 was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow up information received from the quality assurance department on 25 Mar 2013: Updated batch review report.
Age: 52.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Arthralgia, Condition aggravated, Groin pain, Muscular weakness, Pain
Clinical narrative: I began to notice a pain in the upper right groin area. It did not subside but continued to increase. The next day, the pain was significantly worse in the localized in the right hip, causing my right leg to buckle out from underneath me upon trying to bear weight ie, walking.
Age: 52.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Arthralgia, Gait disturbance, Groin pain, Muscular weakness, Weight bearing difficulty
Clinical narrative: I began to notice a pain in the upper right groin area. It did not subside but continued to increase. The next day, the pain was significantly worse in the localized in the right hip, causing my right leg to buckle out from underneath me upon trying to bear weight ie, walking.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Eye swelling, Rash, Visual impairment
Clinical narrative: 20 March 13 Rash and swelling appeared on face. 25 March (Clinic Visit) Rash persisted, difficulty with balance, right eye swollen shut, open vesicle on forehead and in mouth. 26 March (ER visit)  Chest pain, swollen face, difficulty breathing. 26 March (Hospital admission) All above symptoms, pericarditis diagnosed and treated. 27 March (Hospital Discharge).
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Balance disorder, Blister, Chest pain, Dyspnoea, Eyelid oedema
Clinical narrative: 20 March 13 Rash and swelling appeared on face. 25 March (Clinic Visit) Rash persisted, difficulty with balance, right eye swollen shut, open vesicle on forehead and in mouth. 26 March (ER visit)  Chest pain, swollen face, difficulty breathing. 26 March (Hospital admission) All above symptoms, pericarditis diagnosed and treated. 27 March (Hospital Discharge).
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Oral mucosal blistering, Pericarditis, Rash, Swelling face
Clinical narrative: 20 March 13 Rash and swelling appeared on face. 25 March (Clinic Visit) Rash persisted, difficulty with balance, right eye swollen shut, open vesicle on forehead and in mouth. 26 March (ER visit)  Chest pain, swollen face, difficulty breathing. 26 March (Hospital admission) All above symptoms, pericarditis diagnosed and treated. 27 March (Hospital Discharge).
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: Fainting, seizure.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a other health professional refers to a female patient of unknown age with no reported medical history. On 27-FEB-2012 the patient was vaccinated with GARDASIL dose 1 (route, dose and lot number unknown). On 05-SEP-2012 the patient was vaccinated with GARDASIL dose 2 (route, dose and lot number unknown). No other suspect therapies or concomitant medications were reported. On 31-MAR-2013 the patient is in the office to receive her third dose. 27-FEB-2013, 367 days after onset therapy the patient experienced received first dose on 02/27/2012, second on 09/05/2012 is unknown (inappropriate schedule of vaccine administered). Additional information is not expected.
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Chest discomfort, Electrocardiogram T wave inversion, Left ventricular hypertrophy, Troponin normal
Clinical narrative: This study case was received from the investigator in a trial on 15 March 2013. The reporter for this case is the same as for case number 2013-04133 (same subject, same vaccines). A male subject (age and birth date not reported) with no relevant past medical history, developed mild chest pressure and left ventricular hypertrophy, considered mild severity, at two and seven days respectively; after he received an injection of ACAM2000, SP Biologics Co., (lot number, route, site and side not reported); and concomitantly, TYPHOID VACCINE, manufacturer unknown, and ANTHRAX, other manufacturer (lot number, route, site and side not reported) on 06 March 2013. On 08 March 2013, two days post vaccination, the subject experienced mild chest pressure (also reported as the subject reported onset of mild intermittent chest pressure four days post vaccination, lasting three days with no other cardiac symptoms). The event of chest pressure had no exacerbating or alleviating factors and resolved on 10 March 2013. On 13 March 2013, seven days post vaccination, the subject was noted to have an electrocardiogram (ECG) with inverted T-waves and possible left ventricular hypertrophy at lead V2. Rapid and lab Troponin results were reported as normal on unspecified dates. The subject had no other cardiac symptoms and was referred for care, but no follow-up was available. The subject did not take any medications to treat the left ventricular hypertrophy or chest pressure. No concomitant medications were reported. The event of left ventricular hypertrophy was not considered resolved. The subject's outcome was reported as not recovered, lost to follow-up. According to the investigator, the events of left ventricular hypertrophy and chest pressure were considered other important medical events and possibly related to the trial product. Documents held by sender: Medical Record.
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Electrocardiogram normal, Troponin I
Clinical narrative: This study case was received from the investigator in a trial on 16 March 2013. A female subject (birth date not reported) with no significant medical history had received the ACAM2000 (lot number and route not reported) in the left arm on 29 October 2012. The subject also received the following vaccination on 29 October 2012: anthrax vaccine (manufacturer, lot number, route and site not reported). On 01 November 2012, 3 days post vaccination (also reported as 2 days post vaccination), the subject experienced chest pain and chest pressure accompanied by shortness of breath. The symptoms began while standing and lasted approximately 1 minute. Symptoms were ongoing and sporadic since 01 November 2012, with 5 episodes of all listed symptoms. Subject reported "sharp" chest pain and pressure with shortness of breath while exercising, lasting 15 minutes and subsided with rest on 05 November 2012. The chest pain/pressures were moderate in nature. The shortness of breath was also mild. The subject reported no additional symptoms of myopericarditis. The onset date for possible myopericarditis was reported as 01 November 2012. Any actions taken were unknown. The subject took no medications and no medical treatment was sought for these issues. The subject did not deviate from usual daily functions. The subject reported pustules at vaccine site beginning on 02 November 2012 (also reported as 03 November 2012) and ongoing. The shortness of breath, chest pain, and chest pressure were considered possibly related to the vaccine. The pustules were considered very likely related to the vaccine. No additional adverse events were reported. On 05 November 2012, the lab troponin 1 was < 0.10 ng/mL and interpretation of the electrocardiogram (ECG) was normal. The subject was scheduled for an ultrasound of the heart on 08 November 2012. The subject was a 2 on the 5 scale Wong-Baker FACES Rating Scale on 05 November 2012. Subject reported no allergies to medications and no concomitant medications. The subject's status was reported as not recovered. According to the investigator, the event of possible myopericarditis was considered possibly related to vaccination. Documents held by sender: Medical Records.
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Vaccination site pustule
Clinical narrative: This study case was received from the investigator in a trial on 16 March 2013. A female subject (birth date not reported) with no significant medical history had received the ACAM2000 (lot number and route not reported) in the left arm on 29 October 2012. The subject also received the following vaccination on 29 October 2012: anthrax vaccine (manufacturer, lot number, route and site not reported). On 01 November 2012, 3 days post vaccination (also reported as 2 days post vaccination), the subject experienced chest pain and chest pressure accompanied by shortness of breath. The symptoms began while standing and lasted approximately 1 minute. Symptoms were ongoing and sporadic since 01 November 2012, with 5 episodes of all listed symptoms. Subject reported "sharp" chest pain and pressure with shortness of breath while exercising, lasting 15 minutes and subsided with rest on 05 November 2012. The chest pain/pressures were moderate in nature. The shortness of breath was also mild. The subject reported no additional symptoms of myopericarditis. The onset date for possible myopericarditis was reported as 01 November 2012. Any actions taken were unknown. The subject took no medications and no medical treatment was sought for these issues. The subject did not deviate from usual daily functions. The subject reported pustules at vaccine site beginning on 02 November 2012 (also reported as 03 November 2012) and ongoing. The shortness of breath, chest pain, and chest pressure were considered possibly related to the vaccine. The pustules were considered very likely related to the vaccine. No additional adverse events were reported. On 05 November 2012, the lab troponin 1 was < 0.10 ng/mL and interpretation of the electrocardiogram (ECG) was normal. The subject was scheduled for an ultrasound of the heart on 08 November 2012. The subject was a 2 on the 5 scale Wong-Baker FACES Rating Scale on 05 November 2012. Subject reported no allergies to medications and no concomitant medications. The subject's status was reported as not recovered. According to the investigator, the event of possible myopericarditis was considered possibly related to vaccination. Documents held by sender: Medical Records.
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Chest discomfort, Chest pain, Electrocardiogram normal, Troponin I
Clinical narrative: This study case was received from the investigator in a trial on 16 March 2013, with follow-up information on 21 March 2013. A male subject (age and birth date not reported) with no relevant past medical history, (also reported as distant history of Hodgkin's Lymphoma) developed possible myopericarditis, five days after he received an injection of ACAM2000, SP Biologics Co., (lot number, route, site and side not reported); and concomitantly, ANTHRAX, manufacturer unknown (lot number, route, site and side not reported) on 25 October 2012. On 30 October 2012, five days post vaccination, the subject developed possible myopericarditis, considered mild in severity. The subject reported a single episode of mild chest pain and pressure while seated for 20-30 minutes, in the absence of other symptoms. Rapid Troponin I was reported as normal on unspecified date. On 01 November 2012, central lab Troponin I was reported as less than (<) 0.10 ng/mL and an electrocardiogram (ECG) reported as normal. The subject was referred for medical follow-up (also reported as unable to reach subject for information about referral). No treatment medications were prescribed. No concomitant medications were reported. The stop date of possible myopericarditis was reported as resolved on same day, 30 October 2012. The subject was reported as recovered, resolved on 30 October 2012. According to the investigator, the event of possible myopericarditis was considered an other important medical event and possibly related to the trial product. Documents held by sender: Medical Record.
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Bronchitis, Lymphadenopathy, Nasal congestion, Productive cough, Rhinorrhoea
Clinical narrative: This study case was received from the investigator on 19 March 2013. A male subject (date of birth not reported) had received the following vaccinations on 05 March 2013: ACAM2000 (lot number, route and site not reported), Typhoid (Manufacturer Unknown, lot number, route and site not reported), and Anthrax (Other Manufacturer, lot number, route and site not reported). Nine days later, on 14 March 2013, the subject was found to have an elevated Troponin level. Rapid results for blood draw were negative. The troponin lab values were drawn on 13 March 2013 with an elevated value of 0.12 ng/ml (<0.10). The subject had no cardiac symptoms. The subject also experienced bronchitis which included the symptoms of producing cough, nasal congestion and nasal draining which started on 06 March 2013 and swollen glands which started on 08 March 2013 and stopped on 09 March 2013. Treatment included MUCINEX 600mg twice daily (BID). The subject's troponin will be retested and an ECG will be done when the subject is well enough to come in. The subject's smallpox injection site looked normal. The subject's outcome was not recovered. According to the Investigator, the event of elevated troponin was considered an important event and possibly related. Documents held by sender: None.
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Troponin increased
Clinical narrative: This study case was received from the investigator on 19 March 2013. A male subject (date of birth not reported) had received the following vaccinations on 05 March 2013: ACAM2000 (lot number, route and site not reported), Typhoid (Manufacturer Unknown, lot number, route and site not reported), and Anthrax (Other Manufacturer, lot number, route and site not reported). Nine days later, on 14 March 2013, the subject was found to have an elevated Troponin level. Rapid results for blood draw were negative. The troponin lab values were drawn on 13 March 2013 with an elevated value of 0.12 ng/ml (<0.10). The subject had no cardiac symptoms. The subject also experienced bronchitis which included the symptoms of producing cough, nasal congestion and nasal draining which started on 06 March 2013 and swollen glands which started on 08 March 2013 and stopped on 09 March 2013. Treatment included MUCINEX 600mg twice daily (BID). The subject's troponin will be retested and an ECG will be done when the subject is well enough to come in. The subject's smallpox injection site looked normal. The subject's outcome was not recovered. According to the Investigator, the event of elevated troponin was considered an important event and possibly related. Documents held by sender: None.
Sex: M
Vaccine: SMALL
Symptoms: Activities of daily living impaired, Chest discomfort, Chest pain, Cold sweat, Dizziness
Clinical narrative: This study case was received on 18 and 21 March 2013 from the investigator in a trial. A male subject (age reported as 21 on an EKG dated 01 November 2012) with no relevant past medical history, developed possible myopericarditis 2 days after he received the following vaccine: an injection of ACAM2000 in the right arm. He reported body aches and cold sweats the day of the vaccination, and experienced dizziness the following day that was somewhat alleviated by rest. Two days post vaccination on 27 October 2012 the subject developed chest pain/pressure (1 on a scale of 5) and shortness of breath that was associated with exercise, the episodes lasted 1-45 minutes. The symptoms were reduced but not eliminated with rest; and they interfered with his work. The subject was evaluated by a physician on 30 October 2012 and was prescribed ibuprofen 400 mg every morning for chest pain/pressure. On 01 November 2012 a rapid Troponin test was normal and an EKG was completed that was borderline, but results were pending. The subject was referred for medical follow-up, action taken was unknown at the time of this report. The investigator considered the event to be an "other important medical event". The subject has not recovered. According to the investigator the event was possibly related. Documents held by sender: EKG.
Sex: M
Vaccine: SMALL
Symptoms: Dyspnoea, Electrocardiogram, Pain, Troponin normal
Clinical narrative: This study case was received on 18 and 21 March 2013 from the investigator in a trial. A male subject (age reported as 21 on an EKG dated 01 November 2012) with no relevant past medical history, developed possible myopericarditis 2 days after he received the following vaccine: an injection of ACAM2000 in the right arm. He reported body aches and cold sweats the day of the vaccination, and experienced dizziness the following day that was somewhat alleviated by rest. Two days post vaccination on 27 October 2012 the subject developed chest pain/pressure (1 on a scale of 5) and shortness of breath that was associated with exercise, the episodes lasted 1-45 minutes. The symptoms were reduced but not eliminated with rest; and they interfered with his work. The subject was evaluated by a physician on 30 October 2012 and was prescribed ibuprofen 400 mg every morning for chest pain/pressure. On 01 November 2012 a rapid Troponin test was normal and an EKG was completed that was borderline, but results were pending. The subject was referred for medical follow-up, action taken was unknown at the time of this report. The investigator considered the event to be an "other important medical event". The subject has not recovered. According to the investigator the event was possibly related. Documents held by sender: EKG.
Age: 0.56
Sex: M
Vaccine: DTAP, HEP
Symptoms: Aspiration joint normal, Injection site infection, Injection site movement impairment, Irritability, Nuclear magnetic resonance imaging
Clinical narrative: Initial report was received from a healthcare professional on 21 March 2013. A 6-month-old male patient had received a dose three intramuscular injection in the left thigh of DAPTACEL, lot number C4310BA, and an intramuscular injection of Hepatitis B vaccine (manufacturer and lot number not reported) in the right thigh on 14 March 2013. On 16 March 2013, the patient developed a fever and was seen by a nurse practitioner (NP) on 18 March 2013. The patient was irritable, had difficulty moving left leg and had no fever. The patient was rechecked on 19 March 2013 and admitted to the hospital with a white count of 20,000, negative knee tap and had an MRI. Osteomyelitis was ruled out and the patient was diagnosed with infection in the muscle of the leg. An infectious disease doctor was treating the patient in the hospital. The patient had no illness at the time of vaccination and no past medical history. Outcome was not recovered. Documents held by sender: None.
Age: 0.56
Sex: M
Vaccine: DTAP, HEP
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: Initial report was received from a healthcare professional on 21 March 2013. A 6-month-old male patient had received a dose three intramuscular injection in the left thigh of DAPTACEL, lot number C4310BA, and an intramuscular injection of Hepatitis B vaccine (manufacturer and lot number not reported) in the right thigh on 14 March 2013. On 16 March 2013, the patient developed a fever and was seen by a nurse practitioner (NP) on 18 March 2013. The patient was irritable, had difficulty moving left leg and had no fever. The patient was rechecked on 19 March 2013 and admitted to the hospital with a white count of 20,000, negative knee tap and had an MRI. Osteomyelitis was ruled out and the patient was diagnosed with infection in the muscle of the leg. An infectious disease doctor was treating the patient in the hospital. The patient had no illness at the time of vaccination and no past medical history. Outcome was not recovered. Documents held by sender: None.