chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site anaesthesia, Injection site pain
Clinical narrative: Pt states that her right arm where she received her PNEUMOVAX vaccine was sore 10/9/12. On 12/16/12 she reports that it is still sore and numb, and worried that it is her heart. Pt has Dr. appt.
Sex: M
Vaccine: VARZOS
Symptoms: Oral candidiasis
Clinical narrative: Pt developed thrush on back of tongue.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to unspecified number of patients. The patients was vaccinated with first dose of GARDASIL on an unknown date. The nurse reported that these unspecified number of patients may have received a second dose of GARDASIL late. No adverse event reported. No treatment information was reported. The outcome was unknown. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Night sweats, Pain in extremity, Pyrexia
Clinical narrative: Patient developed fever and sweats the night after the vaccine injection. Patient stated that she passed out (unknown duration). Two days after, she felt much better, but her arm is still sore and there is redness around the injection site (~ 3 inches).
Age: 20.0
Sex: F
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Chest X-ray normal, Chest pain, Dyspnoea
Clinical narrative: This study case was received from the investigator in the trial on 04 December 2012. A 20-year-old female subject received the following vaccinations on 30 July 2012: an injection of ACAM2000 (lot number not reported), an injection of TYPHIM Vi, sanofi pasteur SA (lot number not reported) and anthrax (manufacturer and lot number not reported). The subject had a past medical history of chest pain, chest pressure, dizziness/fainting spells, and shortness of breath. On 09 August 2012, the subject had a normal electrocardiogram (ECG) and on 10 August 2012, the subject had a normal echocardiogram. Troponin I results abnormal at 14.18 on 11 August 2012. On 10 August 2012, the subject was diagnosed with unspecified disease of pericardium. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 20.0
Sex: F
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Echocardiogram normal, Electrocardiogram ST segment elevation, Troponin I increased, Troponin T increased
Clinical narrative: This study case was received from the investigator in the trial on 04 December 2012. A 20-year-old female subject received the following vaccinations on 30 July 2012: an injection of ACAM2000 (lot number not reported), an injection of TYPHIM Vi, sanofi pasteur SA (lot number not reported) and anthrax (manufacturer and lot number not reported). The subject had a past medical history of chest pain, chest pressure, dizziness/fainting spells, and shortness of breath. On 09 August 2012, the subject had a normal electrocardiogram (ECG) and on 10 August 2012, the subject had a normal echocardiogram. Troponin I results abnormal at 14.18 on 11 August 2012. On 10 August 2012, the subject was diagnosed with unspecified disease of pericardium. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 20.0
Sex: F
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Echocardiogram normal, Electrocardiogram normal, Pericardial disease, Troponin I increased
Clinical narrative: This study case was received from the investigator in the trial on 04 December 2012. A 20-year-old female subject received the following vaccinations on 30 July 2012: an injection of ACAM2000 (lot number not reported), an injection of TYPHIM Vi, sanofi pasteur SA (lot number not reported) and anthrax (manufacturer and lot number not reported). The subject had a past medical history of chest pain, chest pressure, dizziness/fainting spells, and shortness of breath. On 09 August 2012, the subject had a normal electrocardiogram (ECG) and on 10 August 2012, the subject had a normal echocardiogram. Troponin I results abnormal at 14.18 on 11 August 2012. On 10 August 2012, the subject was diagnosed with unspecified disease of pericardium. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Asthenia, Blood pressure increased, Chest discomfort, Chills, Discomfort
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 10 December 2012. A female patient (age and date of birth not reported) received an intradermal injection of FLUZONE Intradermal (lot number, site and date of administration not reported) "6 days ago". The patient experienced tachycardia with a heart rate (HR) of 100 off and on for the past five days, weakness, dizziness, fatigue, shaking, spiked blood pressure and neuropathy of one leg non-specific. The patient claimed she had EKG changes and the physician ordered tests but not specific on what ones were ordered. Outcome was unknown. Documents held by sender: None.
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Dizziness, Feeling cold, Oropharyngeal discomfort, Pharyngeal oedema, Tachycardia
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 10 December 2012. A female patient (age and date of birth not reported) received an intradermal injection of FLUZONE Intradermal (lot number, site and date of administration not reported) "6 days ago". The patient experienced tachycardia with a heart rate (HR) of 100 off and on for the past five days, weakness, dizziness, fatigue, shaking, spiked blood pressure and neuropathy of one leg non-specific. The patient claimed she had EKG changes and the physician ordered tests but not specific on what ones were ordered. Outcome was unknown. Documents held by sender: None.
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Tremor
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 10 December 2012. A female patient (age and date of birth not reported) received an intradermal injection of FLUZONE Intradermal (lot number, site and date of administration not reported) "6 days ago". The patient experienced tachycardia with a heart rate (HR) of 100 off and on for the past five days, weakness, dizziness, fatigue, shaking, spiked blood pressure and neuropathy of one leg non-specific. The patient claimed she had EKG changes and the physician ordered tests but not specific on what ones were ordered. Outcome was unknown. Documents held by sender: None.
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Chills, Feeling abnormal, Feeling of body temperature change, Palpitations, Throat irritation
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 10 December 2012. A female patient (age and date of birth not reported) received an intradermal injection of FLUZONE Intradermal (lot number, site and date of administration not reported) "6 days ago". The patient experienced tachycardia with a heart rate (HR) of 100 off and on for the past five days, weakness, dizziness, fatigue, shaking, spiked blood pressure and neuropathy of one leg non-specific. The patient claimed she had EKG changes and the physician ordered tests but not specific on what ones were ordered. Outcome was unknown. Documents held by sender: None.
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Asthenia, Blood pressure increased, Dizziness, Electrocardiogram abnormal, Fatigue
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 10 December 2012. A female patient (age and date of birth not reported) received an intradermal injection of FLUZONE Intradermal (lot number, site and date of administration not reported) "6 days ago". The patient experienced tachycardia with a heart rate (HR) of 100 off and on for the past five days, weakness, dizziness, fatigue, shaking, spiked blood pressure and neuropathy of one leg non-specific. The patient claimed she had EKG changes and the physician ordered tests but not specific on what ones were ordered. Outcome was unknown. Documents held by sender: None.
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Neuropathy peripheral, Tachycardia, Tremor
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 10 December 2012. A female patient (age and date of birth not reported) received an intradermal injection of FLUZONE Intradermal (lot number, site and date of administration not reported) "6 days ago". The patient experienced tachycardia with a heart rate (HR) of 100 off and on for the past five days, weakness, dizziness, fatigue, shaking, spiked blood pressure and neuropathy of one leg non-specific. The patient claimed she had EKG changes and the physician ordered tests but not specific on what ones were ordered. Outcome was unknown. Documents held by sender: None.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eye swelling, Skin test negative, Swelling face, Urticaria
Clinical narrative: This spontaneous report was received from a 66 year old female patient regarding herself. The patient reported that back in her sixties she had hives when she penicillin (manufacturer unknown). The patient has drug allergy towards penicillin, VISTARIL and morphine injection. On 19-OCT-2012, the patient was vaccinated with a dose of ZOSTAVAX, (lot number reported as H012578, expiration date and route not reported). Concomitant medications included: influenza virus vaccine (manufacturer unknown) which was administered on 15-OCT-2012. The patient developed hives and rash following the vaccination with ZOSTAVAX on 20-OCT-2012 and they were not at the injection site, but rather on the patients face and head. The hives and rash were described as itchy with swelling of the face, mouth, throat, cheeks and forehead. The patient contacted her pharmacist and was told to take BENADRYL. The patient took liquid BENADRYL and reported that the hives and rash went away after 3 days of treatment (approximately on 23-OCT-2012). Approximately on 10-NOV-2012, the patient (reported as three weeks later), she again developed hives and a rash with itching and swelling on the face that was worser than the original hives and rash. The patient went to the emergency room on 10-NOV-2012, where she was given BENADRYL. On 12-NOV-2012, the patient then went to her physician and was directed to take hydroxyzine and prednisone. The patient took the hydroxyzine and prednisone and reported that on 21-NOV-2012, the hives and rash had resolved. The patient also reported that since 21-NOV-2012, she has has periods (multiple times, unspecified dates), where the hives and rash would come back for 2 to 3 days or a week and then they would resolve. Currently the patient reported that she had a rash on her forehead and two hives on her cheek (start date for current outbreak was unspecified). The patient had been to an allergist for the hives and rash. The allergist did allergy skin tests that were negative. At the time of the report the events rash on her forehead and two hives on her cheek not recovered. The patient sought medical attention not required. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oedema mouth, Pharyngeal oedema, Polymenorrhoea, Pruritus, Rash pruritic
Clinical narrative: This spontaneous report was received from a 66 year old female patient regarding herself. The patient reported that back in her sixties she had hives when she penicillin (manufacturer unknown). The patient has drug allergy towards penicillin, VISTARIL and morphine injection. On 19-OCT-2012, the patient was vaccinated with a dose of ZOSTAVAX, (lot number reported as H012578, expiration date and route not reported). Concomitant medications included: influenza virus vaccine (manufacturer unknown) which was administered on 15-OCT-2012. The patient developed hives and rash following the vaccination with ZOSTAVAX on 20-OCT-2012 and they were not at the injection site, but rather on the patients face and head. The hives and rash were described as itchy with swelling of the face, mouth, throat, cheeks and forehead. The patient contacted her pharmacist and was told to take BENADRYL. The patient took liquid BENADRYL and reported that the hives and rash went away after 3 days of treatment (approximately on 23-OCT-2012). Approximately on 10-NOV-2012, the patient (reported as three weeks later), she again developed hives and a rash with itching and swelling on the face that was worser than the original hives and rash. The patient went to the emergency room on 10-NOV-2012, where she was given BENADRYL. On 12-NOV-2012, the patient then went to her physician and was directed to take hydroxyzine and prednisone. The patient took the hydroxyzine and prednisone and reported that on 21-NOV-2012, the hives and rash had resolved. The patient also reported that since 21-NOV-2012, she has has periods (multiple times, unspecified dates), where the hives and rash would come back for 2 to 3 days or a week and then they would resolve. Currently the patient reported that she had a rash on her forehead and two hives on her cheek (start date for current outbreak was unspecified). The patient had been to an allergist for the hives and rash. The allergist did allergy skin tests that were negative. At the time of the report the events rash on her forehead and two hives on her cheek not recovered. The patient sought medical attention not required. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin test negative, Swelling face, Urticaria
Clinical narrative: This spontaneous report was received from a 66 year old female patient regarding herself. The patient reported that back in her sixties she had hives when she penicillin (manufacturer unknown). The patient has drug allergy towards penicillin, VISTARIL and morphine injection. On 19-OCT-2012, the patient was vaccinated with a dose of ZOSTAVAX, (lot number reported as H012578, expiration date and route not reported). Concomitant medications included: influenza virus vaccine (manufacturer unknown) which was administered on 15-OCT-2012. The patient developed hives and rash following the vaccination with ZOSTAVAX on 20-OCT-2012 and they were not at the injection site, but rather on the patients face and head. The hives and rash were described as itchy with swelling of the face, mouth, throat, cheeks and forehead. The patient contacted her pharmacist and was told to take BENADRYL. The patient took liquid BENADRYL and reported that the hives and rash went away after 3 days of treatment (approximately on 23-OCT-2012). Approximately on 10-NOV-2012, the patient (reported as three weeks later), she again developed hives and a rash with itching and swelling on the face that was worser than the original hives and rash. The patient went to the emergency room on 10-NOV-2012, where she was given BENADRYL. On 12-NOV-2012, the patient then went to her physician and was directed to take hydroxyzine and prednisone. The patient took the hydroxyzine and prednisone and reported that on 21-NOV-2012, the hives and rash had resolved. The patient also reported that since 21-NOV-2012, she has has periods (multiple times, unspecified dates), where the hives and rash would come back for 2 to 3 days or a week and then they would resolve. Currently the patient reported that she had a rash on her forehead and two hives on her cheek (start date for current outbreak was unspecified). The patient had been to an allergist for the hives and rash. The allergist did allergy skin tests that were negative. At the time of the report the events rash on her forehead and two hives on her cheek not recovered. The patient sought medical attention not required. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 years old female patient. The patient was vaccinated with a dose of ZOSTAVAX (lot # 671786/0254AE) (Subcutaneous in left arm) on 11-SEP-2012. Other suspect therapies included FLUZONE (lot# was unknown) on 11-SEP-2012 in the same arm at the same visit for ZOSTAVAX. There was no concomitant medications. After one week vaccination, on 18-SEP-2012 the patient experienced pain and burning at the ZOSTAVAX injection site. The patient experienced the pain when she moved her arm back and up. The patient contacted physician for medical attention and unspecified antibiotic was given for the adverse events. The outcome of pain and burning at the ZOSTAVAX injection site was reported as not recovered/not resolved. Additional information is not expected.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Drug administered at inappropriate site, Pain
Clinical narrative: Severe pain in shoulder joint. Vaccine was administered very high. Persistent pain and frozen shoulder. Reported to primary care 12/05/2012.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal pain, Pain, Periarthritis, X-ray normal
Clinical narrative: Severe pain in shoulder joint. Vaccine was administered very high. Persistent pain and frozen shoulder. Reported to primary care 12/05/2012.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Rash
Clinical narrative: Approx. 1 min after receiving vaccinations she started having a rash on her scalp.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Axillary pain, Drug administered at inappropriate site, Impaired driving ability, Mobility decreased
Clinical narrative: Difficulty with moving arm > than 45 degree angle. Pain under armpit. Can't lay on side. Difficulty dressing & driving. Started aching that day but slowly got worse. TYLENOL & Ibuprofen ineffective. Pt says was RN and shot administered in "joint".
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Difficulty with moving arm > than 45 degree angle. Pain under armpit. Can't lay on side. Difficulty dressing & driving. Started aching that day but slowly got worse. TYLENOL & Ibuprofen ineffective. Pt says was RN and shot administered in "joint".
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Injection site erythema, Injection site rash, Rash generalised, Skin warm
Clinical narrative: Immun given 12/11/12 11:40 AM 1 time flu shot also given 6 month old shots Mom called AM pt. rash "all over" mom brought child to office red rash thigh flat warm pictures face, chest, back.
Age: 0.48
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Injection site reaction, Pyrexia
Clinical narrative: Vaccine given approx 9:30 fever. 645 PM Leg reaction.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 11 December 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 12-month-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3784AA received on 26 April 2011, lot number C3926AA received on 13 June 2011, and lot number C3879AA received on 23 August 2011. The subject developed a cough on 07 March 2012, approximately 6 months after the last dose, and a paroxysmal cough with a whoop on 15 March 2012. The subject also developed cold like symptoms on 07 March 2012, posttusive vomiting and sleep disturbance (start dates not reported). Laboratory testing included positive PCR on 16 March 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 16 March 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 27 March 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 20 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 11 December 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 12-month-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3784AA received on 26 April 2011, lot number C3926AA received on 13 June 2011, and lot number C3879AA received on 23 August 2011. The subject developed a cough on 07 March 2012, approximately 6 months after the last dose, and a paroxysmal cough with a whoop on 15 March 2012. The subject also developed cold like symptoms on 07 March 2012, posttusive vomiting and sleep disturbance (start dates not reported). Laboratory testing included positive PCR on 16 March 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 16 March 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 27 March 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 20 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Oedema peripheral
Clinical narrative: (L) arm red, swelling. BENADRYL, AMOX 250/5.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a unspecified number of patients (gender and age unknown). Over the past 3 months (since approximately September 2012) the patients were vaccinated with a dose of GARDASIL (lot number, route and dose were not reported). The nurse reported that the patients may have received improperly stored GARDASIL over the past three months. No symptoms were reported. No other details were provided. This case is related to case MARRS # 1212USA005493 and case MARRS # 1212USA005494 (same reporter link). Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: ANTH, FLUN3, SMALL, TYP
Symptoms: Pericardial disease
Clinical narrative: This study case was received from the investigator on 05 December 2012. A 24-year-old male subject received the following vaccinations on 22 August 2012: an injection of ACAM2000 (lot number not reported), an injection of TYPHIM VI, sanofi pasteur SA (lot number not reported) a dose of Influenza, live, intranasal (manufacturer and lot number not reported) and ANTHRAX (manufacturer and lot number not reported). Medical history and laboratory/diagnostic tests were unavailable. On 02 September 2012, the subject was diagnosed with unspecified disease of pericardium. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Rash
Clinical narrative: 10-12 cm area on right upper arm. Has redness, warm to touch, pain and swelling. Rash arose quickly and started to spontaneously resolve. Treated with prednisone 40 mg x 5 days.
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis, Polymerase chain reaction
Clinical narrative: Initial report received on 04 December 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 13-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL on 01 December 2011, 02 February 2012, and 03 April 2012 (lot numbers, routes and sites of administration not reported). The subject developed a cough on 07 November 2012, approximately 7 months after the last dose, and a paroxysmal cough without a whoop on 08 November 2012. The subject also developed posttusive vomiting and sleep disturbance (start dates not reported). Laboratory testing included positive PCR on 09 November 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 09 November 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 28 November 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 04 December 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 13-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL on 01 December 2011, 02 February 2012, and 03 April 2012 (lot numbers, routes and sites of administration not reported). The subject developed a cough on 07 November 2012, approximately 7 months after the last dose, and a paroxysmal cough without a whoop on 08 November 2012. The subject also developed posttusive vomiting and sleep disturbance (start dates not reported). Laboratory testing included positive PCR on 09 November 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 09 November 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 28 November 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient complaint that arm has been sore since receiving shot & is to the point where it can't move
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain
Clinical narrative: This study case was received from the investigator in the trial on 04 December 2012. A 24-year-old male subject received an injection of ACAM2000 (lot number not reported) on 19 July 2012. Medical history and laboratory/diagnostic testing were unavailable. On 26 July 2012, the subject was diagnosed with chest pain, unspecified. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 31.0
Sex: M
Vaccine: ANTH, FLUN3, SMALL
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Electrocardiogram abnormal, Headache
Clinical narrative: This study case was received from the investigator in a trial on 30 November 2012. A 31-year-old male subject had received the following vaccinations on 15 November 2012: ACAM2000 (lot number and route not reported) in the left arm, anthrax vaccine (manufacturer, lot number, route and site not reported) and FLUMIST (lot number, route and site not reported). Eight days post-vaccination on 23 November 2012, the subject experienced onset of chest pain, chest pressure and shortness of breath that was exacerbated by wearing combat gear. All symptoms are in the middle of chest and are a constant sharp pain. The subject also reported headaches since one day post-vaccination on 16 November 2012. The subject started taking ADVIL for the symptoms on 16 November 2012. The subject was evaluated by the provider before visit two. No ECG or labs were performed and the subject returned to full duty. On 28 November 2012, an ECG was done that was abnormal. Troponin I was increased at 0.13 ng/ml. The subject had an allergy to penicillin and had frequent headaches since 1984. No further information was available at the time of the report. The subject's outcome was not recovered. According to the investigator, the event of elevated Troponin was considered another important event and possibly related to vaccination. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: None.
Age: 31.0
Sex: M
Vaccine: ANTH, FLUN3, SMALL
Symptoms: Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 30 November 2012. A 31-year-old male subject had received the following vaccinations on 15 November 2012: ACAM2000 (lot number and route not reported) in the left arm, anthrax vaccine (manufacturer, lot number, route and site not reported) and FLUMIST (lot number, route and site not reported). Eight days post-vaccination on 23 November 2012, the subject experienced onset of chest pain, chest pressure and shortness of breath that was exacerbated by wearing combat gear. All symptoms are in the middle of chest and are a constant sharp pain. The subject also reported headaches since one day post-vaccination on 16 November 2012. The subject started taking ADVIL for the symptoms on 16 November 2012. The subject was evaluated by the provider before visit two. No ECG or labs were performed and the subject returned to full duty. On 28 November 2012, an ECG was done that was abnormal. Troponin I was increased at 0.13 ng/ml. The subject had an allergy to penicillin and had frequent headaches since 1984. No further information was available at the time of the report. The subject's outcome was not recovered. According to the investigator, the event of elevated Troponin was considered another important event and possibly related to vaccination. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: None.
Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: Cardiac failure congestive, Dyspnoea, Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram abnormal
Clinical narrative: Vaccine on 5/20/11 noticed shortness of breath in Aug 2011. Thought I was just out of shape. Winter came then in March 2012 I went for a walk. Really out of breath. Went to dr. EKG - Echocardiogram. Tests - Diagnosis CHF.
Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: Laboratory test abnormal
Clinical narrative: Vaccine on 5/20/11 noticed shortness of breath in Aug 2011. Thought I was just out of shape. Winter came then in March 2012 I went for a walk. Really out of breath. Went to dr. EKG - Echocardiogram. Tests - Diagnosis CHF.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Local reaction, Skin warm, Swelling
Clinical narrative: 12-13-12 shot given. Woke up 12-14-12 with swollen, red, warm localized reaction. By afternoon progressed to baseball sized area - red, swollen, warm. 12-17-12 arm is much better "almost gone".
Age: 61.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Bilateral deltoid muscle sites: pain, swelling and redness. Now no fever, pain 3/10. Treatment by PA: BACTRIM DS 1 BID - 10 days.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pancreatitis
Clinical narrative: Administered 7/15/2011. Patient suffered pancreatitis October (mid) 2011. Required admission and treatment.
Age: 48.0
Sex: M
Vaccine: ANTH, HEP, HEPA, SMALL, TYP
Symptoms: Back disorder, Hearing impaired, Hypertension, Insomnia, Intervertebral disc protrusion
Clinical narrative: High blood pressure, nervousness, insomnia, general body pain, lower back problems, thyroid problems, hearing problems.
Age: 48.0
Sex: M
Vaccine: ANTH, HEP, HEPA, SMALL, TYP
Symptoms: Nerve compression, Nervousness, Pain, Thyroid disorder
Clinical narrative: High blood pressure, nervousness, insomnia, general body pain, lower back problems, thyroid problems, hearing problems.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Initial report was received from a healthcare professional on 07 December 2012. A nine-year-old female patient had received an injection in the left deltoid of FLUZONE, lot number UH734AD, on 04 December 2012. The day after vaccination on 05 December 2012, the patient began having symptoms of redness, swelling and the area felt firm at the left deltoid area. The physician stated that the vaccine may have been given lower than the deltoid muscle and possibly not into the muscle. The redness has lightened, but continues to increase in size and swelling has increased. The physician stated it may be cellulitis. The patient is able to move her arm without discomfort or restrictions. Treatment included OMNICEF, ORAPRED and BENADRYL. The patient had no illness at the time of vaccination and no past medical history. No laboratory or diagnostic testing was provided. Outcome was not recovered. Documents held by sender: None.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, RVX
Symptoms: Pyrexia, Seizure like phenomena, Vomiting
Clinical narrative: Initial report was received from a healthcare professional on 05 December 2012. This patient also experienced another adverse event which was captured in case number 2012-11686. A five-month-old female patient received a dose of PENTACEL and a dose of Rotavirus (lot numbers, routes and sites of administration not reported) on 07 November 2011 and an unspecified amount of time later experienced vomiting, fever and seizure like activity. The patient had no illness at the time of vaccination and no known allergies (NKA). The patient experienced fever and vomiting right after receiving PENTACEL, hepatitis B vaccine, Rotavirus vaccine and PNEUMOVAX (captured in case number 2012-11686). Outcome was unknown. Documents held by sender: None.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis, Injection site rash
Clinical narrative: Initial report was received from a healthcare professional on 06 December 2012. A 29-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE, lot number UH713AB, on 24 November 2012 and a half hour after the injection the patient had a rash at the injection site. It was learned later that the patient developed a cellulitis at the injection site and was hospitalized. Treatment included intravenous (IV) antibiotics. The physician told the patient's parent that the event may be a flesh eating disease. The patient had no illness at the time of vaccination, an allergy to penicillin (PCN) and a history of diabetes. Outcome was not recovered. Documents held by sender: None.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU3, IPV
Symptoms: Partial seizures, Pyrexia
Clinical narrative: This case was reported by a physician and described the occurrence of multiple focal seizures in a 5-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent vaccination included poliomyelitis vaccine inactivated (non-gsk); Sanofi; unknown; unknown given on 3 December 2012; seasonal influenza vaccine (non-gsk); Sanofi; unknown; unknown given on 3 December 2012. On 3 December 2012 at 15:00 the subject received 5th dose of INFANRIX (.5 ml, unknown route, left thigh). On 7 December 2012 at 03:00, 4 days after vaccination with INFANRIX, the subject experienced multiple focal seizures ("multi focal seizures") and fever. The subject was hospitalised and the physician considered the events were disabling and life threatening. At the time of reporting the outcome of the events of multiple focal seizures was unresolved. The physician reported that "the seizures were not under control yet." The subject "remains in the hospital at the time of the report." At the time of reporting, the outcome of the fever was unknown. The physician considered the event of seizures was probably related to vaccination with INFANRIX. The physician considered the event of fever unrelated to vaccination with INFANRIX.
Age: 12.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Oedema peripheral
Clinical narrative: Injection given at 905AM. Arm began swelling in first 5 minutes. Pt given BENADRYL and observed for 25 minutes.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Injection site rash, Paraesthesia, Rash vesicular
Clinical narrative: Rash at site of injection, tingling, burning began the day after vaccine given. Then vesicular rash, spreading. Seen in office 12/10/12. Dx with Herpes Zoster, Tx with VALTREX 1 gm tid x 10 days.
Age: 1.04
Sex: F
Vaccine: FLUN3, MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, Expired drug administered
Clinical narrative: Flu shot ordered by doctor. Medical Assistant pulled vaccine from refrigerator, gave vaccines to patient per nostril. MA documenting vaccines discovered expiration date passed. MA reported to RN supervisor. RN discovered age inappropriate for mist & protocol not followed. No treatment necessary.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Pain in left upper lateral arm since flu shot. Painful to raise left shoulder.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out after receiving flu shot.
Age: 0.39
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Feeding disorder of infancy or early childhood, Hypersomnia, Vomiting
Clinical narrative: Day after vaccine administration, sleeping more than usual, denied fever, occasional vomiting, normal BM & wet diapers, not feeding as well as usual. 12/17/12 doing better today.
Age: 0.27
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Injection site erythema, Insomnia, Pain
Clinical narrative: Child with inconsolable crying approximately 1 hour after vaccines per mother's statement. Sleeping 15-20 minutes, awakens crying "in pain". Brought to clinic Temp. 99, lungs clear, no swelling noted. Slight erythema (L) thigh, mild. Phoned radio MD, ibuprofen given to child 2 ml, once, per MD orders. Call clinic for any concerns. Spoke with parent 12/12/12 in AM approximately 0830 child slept through night, no other issues noted.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain lower, Activities of daily living impaired, Diarrhoea, Pelvic pain
Clinical narrative: Extreme diarrhea with severe lower abdomen/pelvic pain (stabbing in nature) x 48 hrs - required time off work.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient received FLUZONE HD and states that a month later still suffers from pain in the injection arm. States she felt pain radiate from deltoid all the way down her fingers starting on day of injection.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Insomnia, Pain
Clinical narrative: Child received immunizations 12/11/12. Received phone call at 0255am from mother & grandmother stating child had been crying for hours only sleep approximately 45 minutes before waking crying. Crying "in pain" began approximately 4 hours after shots given. TX 1 Ibuprofen as directed call clinic for any concerns. Client was afebrile per parent, no redness or swelling noted.
Age: 1.52
Sex: M
Vaccine: FLU3
Symptoms: Injection site rash, Injection site reaction, Rash erythematous
Clinical narrative: Localize pink rash around injection site extending to knee.
Age: 1.04
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Full blood count normal, Irritability, Pyrexia, Urine analysis normal
Clinical narrative: Began with fever night of vaccination. Fussy decrease appetite 12/4/12 T-102.9 (A) in office 12/7/12 T- 101.1 (A) in office.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis
Clinical narrative: On 12/10/12, pt approached pharmacist to say she had developed cellulitis from her flu shot. Pt went to Dr. who gave her a steroid shot, XYZAL, PEPCID, and prednisone. The area cleared up with no additional adverse response.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: 102 degree fever; severe body aches; nausea; vomiting; chills.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Flu shot given at 9AM. Rash/hives began at 10:30 PM. BENADRYL taken 10:45 PM. Rash resolved 11:15 PM.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Fatigue, White blood cell count increased
Clinical narrative: Patient reports she is much more tired than usual, and has "trouble catching breath" 24 hour after Tdap. Encouraged MD eval. This report was by phone. Seen on 8/9/12 to read TST. Patient states she was seen for her symptoms. States WBC's were up a little, but nothing else found. Feels fully recovered on 8/9/12. I have not been able to get a release to obtain MD eval results.
Age: 4.0
Sex: F
Vaccine: FLU3, HIBV, MMR, PNC13
Symptoms: Injection site pain, Lymphadenopathy, Pyrexia
Clinical narrative: Fever for 2 days after doses administered and also enlarged lymphoids - bil. size of a quarter at femoral pulse site. Rebound tenderness at site when palpated. Reported at facility on 12-5-12.
Age: 3.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Rash, Rash pruritic
Clinical narrative: Itchy rash covering anterior-posterior trunk.
Age: 20.0
Sex: F
Vaccine: FLUN3, HEPA, HPV4
Symptoms: Pruritus generalised, Skin discolouration
Clinical narrative: Pt & MOP presented back to clinic 20 min after receiving vaccines c/o itching all over, no SOA, no hives. Pt skin ashen from scratching. Vitals 124/96, 118, 24, O2-100%. Pt given BENADRYL 50mg IM, MOP sent to pharmacy to pick up Rx - ATARAX PO.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Blood test, Eye swelling, Rash, Skin lesion
Clinical narrative: Got what at first felt like bug bites on my head. 2 months later started bolding and bumps turned to lesions, eye swell up and rash on my neck. Had a very low WB count. Dermatologist diagnosed with possible cutaneous Lupus (autoimmune disease).
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site.
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Wrong drug administered
Clinical narrative: None. Wrong immunization inadvertently given.
Age: 44.0
Sex: M
Vaccine: FLU3, HEP, HEPA, PPV
Symptoms: Hallucination, visual
Clinical narrative: Hallucination while at home:  "saw" two other men arguing in his room but they were not actually there. Duration a few minutes, resolved spontaneously.
Age: 0.57
Sex: F
Vaccine: DTAPIPV, HIBV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient was administered Kinrix prior to manufacturer recommended age of 4 yrs. No adverse results noted.
Age: 56.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, warmth, swelling 4cm diameter.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Convulsion, Electroencephalogram, Full blood count, Irritability, Metabolic function test
Clinical narrative: Was very fussy the night of vaccinations, stopped screaming and had a seizure.  Per ER report and doctor.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Nuclear magnetic resonance imaging brain, Screaming
Clinical narrative: Was very fussy the night of vaccinations, stopped screaming and had a seizure.  Per ER report and doctor.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Swelling face, Urticaria
Clinical narrative: Hives, facial swelling; injection of methylprednisolone sodium succinate  and Rx for prednisone.  Some itching still present.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Pain
Clinical narrative: The patient experienced pain at the injection site after administration. Redness and inflammation appeared around the injection site on Saturday evening (12/15). The pain worsened and she visited the ED and was sent home and instructed to take Benadryl. She felt better on Sunday (12/16) and even better today (12/17).
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Pyrexia, Urticaria
Clinical narrative: Hard pnk wheal around site of injection.  As day and into next day reaction was from shoulder to elbow.  Inflammation, hardness, fever.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination complication
Clinical narrative: Hard pnk wheal around site of injection.  As day and into next day reaction was from shoulder to elbow.  Inflammation, hardness, fever.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Discomfort, Eye pain, Headache, Herpes zoster
Clinical narrative: Patient with a hx of rheumatoid arthritis who was on active immunosuppressive therapy (specifically, methotrexate, prednisone and Plaquenil) went to an area retail pharmacy and requested and received a varicella zoster vaccine. It was administered by a licensed pharmacist who was certified in vaccine administration. Two weeks later she developed a dermatomal rash low grade fever and mild pain and discomfort in the rash area. Two weeks after the rash onset she began experiencing some left ocular pain, discomfort, and headaches which went on for 2 days. She then developed abrupt onset of decreased vision in that left eye without any other clinical manifestations.  She was seen by her primary ophthalmologist, who made a primary evaluation with possible diagnosis of acute retinal necrosis. She was started on Valtrex 1g TID po on Monday 11/22 and stopped her immunosupression. She was referred to a retinal specialist who admitted her to Hospital. She was seen by Dr. who diagnosed her with acute retinal necrosis secondary to herpes zoster related to recent Zostavax vaccination. I, infectious disease pharmacist, participated in her care in dosing and monitoring of her IV antiviral medications and in reporting of adverse drug events at hospital.