chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Chills, Diarrhoea, Erythema, Nausea, Pain
Clinical narrative: Fevers, chills, body aches, nausea, vomiting, diarrhea, pain, swelling. redness in right arm. Symptoms started on Wednesday 10/30/13 at 1800.
Age: 26.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pyrexia, Swelling, Vomiting
Clinical narrative: Fevers, chills, body aches, nausea, vomiting, diarrhea, pain, swelling. redness in right arm. Symptoms started on Wednesday 10/30/13 at 1800.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of improperly stored PNEUMOVAX23 (lot # H010515, exp. 13-FEB-2014) (dose not provided). This is one of several reports received from the same source (linked MARRS#: 1310USA014883, 1310USA014888, 1310USA014891, 1311USA000056, 1311USA000071, 1310USA015417, 1310USA014897, 1311USA000012, 1310USA014858, 1310USA014850, 1310USA014870, 1311USA000289, 1311USA000282, 1310USA014874, 1310USA014861, 1310USA014866, 1310USA014868, 1310USA015422, 1310USA015165, 1311USA000069, 1310USA015424, 1311USA000058, 1311USA000042, 1311USA000013, 1310USA015170, 1311USA000014, 1310USA015153, 1310USA015090, 1311USA000067, 1311USA000064, 1311USA000020, 1311USA000021, 1311USA000040, 1310USA015096, 1311USA000022, 1310USA015101, 1310USA104853, 1311USA000075, 1310USA014895). Additional information has been requested.
Age: 47.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: 10/24/13 pt received PNEUMOVAX vaccine and flu vaccine. 5 hours later developed pruritic vesicular rash on extremities and face. Treated with prednisone 11/7 - will follow up with dermatology.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a other refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of improperly stored PNEUMOVAX23 (lot # H013394, exp. 05-MAR-2014) (dose not provided). This is one of several reports received from the same source (linked MARRS#: 1310USA014883, 1310USA014888, 1310USA014891, 1311USA000056, 1311USA000071, 1310USA015417, 1310USA014897, 1311USA000012, 1310USA014858, 1310USA014850, 1310USA014870, 1311USA000289, 1311USA000282, 1310USA014874, 1310USA014861, 1310USA014866, 1310USA014868, 1310USA015422, 1310USA015165, 1311USA000069, 1310USA015424, 1311USA000058, 1311USA000042, 1311USA000013, 1310USA015170, 1311USA000014, 1310USA015153, 1310USA015090, 1311USA000067, 1311USA000064, 1311USA000020, 1311USA000021, 1311USA000040, 1310USA015096, 1311USA000022, 1310USA015101, 1310USA014853, 1311USA000075, 1310USA014895, 1311USA000040). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse on behalf of an unspecified patient's mother refers to a patient of unknown age and gender about the "binding agent" in M-M-R II. The patient was vaccinated with a dose of M-M-R II (lot# 12376, expiry date: 28-AUG-2010) (dose, route and location unspecified) in 2008. The reporter stated that she was unsure if the patient had any reactions to the M-M-R II but stated that the patient will be seeing unspecified specialist for an unspecified reason on an unspecified date. At the time of report, the outcome of the event was unknown. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Influenza like illness, Nausea, Pain
Clinical narrative: At 8 hours after vaccination patient awoke with severe chills, diarrhea, nausea, body aches "felt like flu".
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Musculoskeletal pain
Clinical narrative: This spontaneous report refers to a 62 year old female patient with high blood pressure, depression and drug reactions/allergies with Sulfur (hives). On 05-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, frequency and route not reported). Concomitant medication included unspecified antidepressant and unspecified blood pressure medication. The patient reported that she had had shoulder pain and a small rash around the injection site since she received ZOSTAVAX on 06-OCT-2013. The patient sought medical attention by speaking with the pharmacist. No lab diagnostics studies performed. The outcome of the event was not recovered. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 4 patients. On unknown date, the 4 patients received VARIVAX (Merck) (lot H017010 exp 12-SEP-2014) which was exposed to refrigerator temperatures not greater than 46F for an unknown period of time. VARIVAX (Merck) was not supported due to inability to determine the length of time of the excursion. The medical assistant stated she would call back with the administration dates of the 4 patients. No adverse symptoms reported. This link is linked with 1311USA000101 as received from the same source. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia oral
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 74 year old male patient with no drug reactions/allergies. On 24-OCT-2013 the patient was vaccinated with a single dose of ZOSTAVAX (reported lot # J006830, expiration date 14-SEP-2014, dose not reported, subcutaneously). Concomitant therapies included VOLTAREN and CIALIS. On an unknown date in 2013 the patient experienced lower lip numbness. There was no treatment given for the event. No lab diagnostic studies performed. The patient sought medical attention via called pharmacy. The outcome of the event was reported as recovered/resolved on an unknown date in 2013. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test normal, Chest discomfort, Influenza like illness, Oropharyngeal pain, Sinus congestion
Clinical narrative: This spontaneous report as received from a consumer refers to an 80 year old male patient. The patient's medical history included blood pressure abnormal and severe muscle pain after use with unspecified statin medication. The patient had 2 prior boughts with shingles and patient took a prior prednisone (manufacturer unknown) regimen before receiving the vaccine. On 22-AUG-2013 the patient was vaccinated with ZOSTAVAX, vial, 0.65 ml (standard dose), injection, lot # and frequency unspecified. Concomitant therapies included prednisone (manufacturer unknown), acetaminophen, NORCO, unspecified blood pressure medication, "Pertonic", and unspecified water pill, and an unspecified potassium pill. On 22-AUG-2013, after receiving the ZOSTAVAX vaccine, he began to "feel like he was coming down with the flu". The patient felt as stuffiness in his eyes and head, the beginning of a sore throat, and slight discomfort in his chest. The symptoms were begun on a consistent basis in the evenings. Treatment of 20 mg daily of prednisone (manufacturer unknown) was given for the events. Routine blood work was taken and with normal results. Patient sought medical attention via office visit. The outcome of the events was reported as not recovered/not resolved (also reported "the symptoms had lessened some/lighted up since the, but this still happened as night"). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to five patients of unknown age. On 30-OCT-2013 the patients were vaccinated with a expired dose of ZOSTAVAX (lot # 672867/0241AE, expired on 26-APR-2013). No adverse effect reported. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 31-OCT-2013 the patient was vaccinated with a expired dose of ZOSTAVAX (lot # 672867/0241AE, expired on 26-APR-2013). No adverse effect reported. This is one of several reports received from same source. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 year old female patient. On 04-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX, (lot # J003806, Exp date 03-JUL-2014), 0.65 ml, subcutaneous. On 05-OCT-2013, the patient came back to see the pharmacist to show her the injection site which was red, warm, swollen, itchy and painful. The pharmacist stated she did not recommend any particular treatment for the injection site reaction. On 14-OCT-2013, the patient returned to the pharmacy to follow up with the pharmacist who stated that the patient's injection site was getting better. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 year old female patient. On 04-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX, (lot # J003806, Exp date 03-JUL-2014), 0.65 ml, subcutaneous. On 05-OCT-2013, the patient came back to see the pharmacist to show her the injection site which was red, warm, swollen, itchy and painful. The pharmacist stated she did not recommend any particular treatment for the injection site reaction. On 14-OCT-2013, the patient returned to the pharmacy to follow up with the pharmacist who stated that the patient's injection site was getting better. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Asthenia, Blood test normal, Computerised tomogram normal, Death, Dysstasia
Clinical narrative: This case was reported by a pharmacist via sales representative and described the occurrence of death (cause unknown) in a 46-year-old male who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). On 4 September 2013 the subject received a dose of FLUARIX QUADRIVALENT (unknown details). On 16 September 2013, 12 days after vaccination with FLUARIX QUADRIVALENT, the subject experienced hospitalization. The cause of the hospitalization was not reported. On 27 September 2013, 23 days after vaccination with FLUARIX QUADRIVALENT, the subject experienced death (cause unknown). The healthcare professional considered the event was related to vaccination with FLUARIX QUADRIVALENT. Per the reporter, the "reported seemed to contribute the death to the vaccination". The event was reported to "hospital safety department." The subject died, cause of death is not specified. It was unknown whether an autopsy was performed.
Age: 46.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Gait disturbance, Grip strength decreased, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: This case was reported by a pharmacist via sales representative and described the occurrence of death (cause unknown) in a 46-year-old male who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). On 4 September 2013 the subject received a dose of FLUARIX QUADRIVALENT (unknown details). On 16 September 2013, 12 days after vaccination with FLUARIX QUADRIVALENT, the subject experienced hospitalization. The cause of the hospitalization was not reported. On 27 September 2013, 23 days after vaccination with FLUARIX QUADRIVALENT, the subject experienced death (cause unknown). The healthcare professional considered the event was related to vaccination with FLUARIX QUADRIVALENT. Per the reporter, the "reported seemed to contribute the death to the vaccination". The event was reported to "hospital safety department." The subject died, cause of death is not specified. It was unknown whether an autopsy was performed.
Age: 46.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Intensive care, Lumbar puncture abnormal, Nerve conduction studies abnormal, Paraesthesia, Pulseless electrical activity
Clinical narrative: This case was reported by a pharmacist via sales representative and described the occurrence of death (cause unknown) in a 46-year-old male who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). On 4 September 2013 the subject received a dose of FLUARIX QUADRIVALENT (unknown details). On 16 September 2013, 12 days after vaccination with FLUARIX QUADRIVALENT, the subject experienced hospitalization. The cause of the hospitalization was not reported. On 27 September 2013, 23 days after vaccination with FLUARIX QUADRIVALENT, the subject experienced death (cause unknown). The healthcare professional considered the event was related to vaccination with FLUARIX QUADRIVALENT. Per the reporter, the "reported seemed to contribute the death to the vaccination". The event was reported to "hospital safety department." The subject died, cause of death is not specified. It was unknown whether an autopsy was performed.
Age: 46.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Unresponsive to stimuli
Clinical narrative: This case was reported by a pharmacist via sales representative and described the occurrence of death (cause unknown) in a 46-year-old male who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). On 4 September 2013 the subject received a dose of FLUARIX QUADRIVALENT (unknown details). On 16 September 2013, 12 days after vaccination with FLUARIX QUADRIVALENT, the subject experienced hospitalization. The cause of the hospitalization was not reported. On 27 September 2013, 23 days after vaccination with FLUARIX QUADRIVALENT, the subject experienced death (cause unknown). The healthcare professional considered the event was related to vaccination with FLUARIX QUADRIVALENT. Per the reporter, the "reported seemed to contribute the death to the vaccination". The event was reported to "hospital safety department." The subject died, cause of death is not specified. It was unknown whether an autopsy was performed.
Age: 46.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Death
Clinical narrative: This case was reported by a pharmacist via sales representative and described the occurrence of death (cause unknown) in a 46-year-old male who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). On 4 September 2013 the subject received a dose of FLUARIX QUADRIVALENT (unknown details). On 16 September 2013, 12 days after vaccination with FLUARIX QUADRIVALENT, the subject experienced hospitalization. The cause of the hospitalization was not reported. On 27 September 2013, 23 days after vaccination with FLUARIX QUADRIVALENT, the subject experienced death (cause unknown). The healthcare professional considered the event was related to vaccination with FLUARIX QUADRIVALENT. Per the reporter, the "reported seemed to contribute the death to the vaccination". The event was reported to "hospital safety department." The subject died, cause of death is not specified. It was unknown whether an autopsy was performed.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: This spontaneous report as received from a female pharmacist of unknown age via a field representative refers to herself. On an unknown date (reported as years ago), the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose, frequency, route not reported). On an unknown date, the patient developed redness, warmth and "tiny bumps" at the injection site after administration of ZOSTAVAX "years ago". She sought unknown type of medical attention. The symptoms resolved after 1 week. The pharmacist stated that she reported this adverse event to Merck years ago but a case could not be identified. Additional information is not expected.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Condition aggravated, Epilepsy, Petit mal epilepsy
Clinical narrative: Pt experienced a seizure after receivng vaccine.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Convulsion
Clinical narrative: Pt experienced a seizure after receivng vaccine.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Immediate post-injection reaction, Partial seizures
Clinical narrative: Pt experienced a seizure after receivng vaccine.
Sex: M
Vaccine: FLUX
Symptoms: Influenza, Oropharyngeal pain, Vomiting
Clinical narrative: This non-medically confirmed spontaneous report (initial receipt 25-Oct-2013), concerns a male patient. The patient previously had received half doses of influenza vaccine as he had a sulfite allergy and would get sick if administered a full dose at one time. The reporter stated that the patient received half doses of the influenza vaccine every time he was administered it and he still got sick. On an unspecified date, the patient received a half dose of unspecified influenza vaccine (manufacturer and batch number not specified). On an unspecified date, after the administration of the influenza vaccine, the patient developed the flu, a sore throat and threw up. Outcome was not reported.
Sex: F
Vaccine: PPV
Symptoms: Adverse reaction, Injection site rash
Clinical narrative: This spontaneous report as received from a nurse refers to a female nurse of unknown age. On an unspecified date in October 2013 the patient was vaccinated with a dose of PNEUMOVAX23, injection, (lot#, strength and indication not reported), 0.5 ml, intramuscular. On an unspecified date the patient experienced a rash at the PNEUMOVAX23 injection site and an unspecified, systemic reaction and "had to stay in the hospital for a few days". At the time of reporting, the outcome of events was reported as recovering. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from an unknown reporter refers to a patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II (lot # H018949, expiry date: 18-OCT-2014, therapy type, dose, route were unknown), which was improperly stored vaccine. This is one of several reports that received from the same source. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from an unknown reporter refers to a patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II (lot # H014649, expiry date: 08-MAR-2014, therapy type, dose, route were unknown), which was improperly stored vaccine. This is one of several reports that received from the same source. Additional information is not expected.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Fatigue, Gait disturbance, Hyperhidrosis, Lymphadenopathy
Clinical narrative: S) Developed fatigue, migraine-like headache, diaphoresis, fever, weakness, (R)-sided stiffness approx 9 1/2' hrs. after flu vacc. O) T 98.0. Antalgic gate. Sclera erythematous. Macular papular rash (poison ivy, which pt got for 1st time on 11/5/13) on forearms. Cervical/axillary adenopathy. S1 S2, RRR, Lungs CTA MS 4-5/5 RUE and RLE and 5/5 on left. A) Rxn to flu; P) ADVIL prn. OOW Vacc 11/7/13 and 11/8/13. Occ Health 11/.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Migraine, Musculoskeletal stiffness, Ocular hyperaemia, Pyrexia, Rash maculo-papular
Clinical narrative: S) Developed fatigue, migraine-like headache, diaphoresis, fever, weakness, (R)-sided stiffness approx 9 1/2' hrs. after flu vacc. O) T 98.0. Antalgic gate. Sclera erythematous. Macular papular rash (poison ivy, which pt got for 1st time on 11/5/13) on forearms. Cervical/axillary adenopathy. S1 S2, RRR, Lungs CTA MS 4-5/5 RUE and RLE and 5/5 on left. A) Rxn to flu; P) ADVIL prn. OOW Vacc 11/7/13 and 11/8/13. Occ Health 11/.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination complication
Clinical narrative: S) Developed fatigue, migraine-like headache, diaphoresis, fever, weakness, (R)-sided stiffness approx 9 1/2' hrs. after flu vacc. O) T 98.0. Antalgic gate. Sclera erythematous. Macular papular rash (poison ivy, which pt got for 1st time on 11/5/13) on forearms. Cervical/axillary adenopathy. S1 S2, RRR, Lungs CTA MS 4-5/5 RUE and RLE and 5/5 on left. A) Rxn to flu; P) ADVIL prn. OOW Vacc 11/7/13 and 11/8/13. Occ Health 11/.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old female patient with no drug reactions or allergies. On 23-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot# J004310, Exp date 07/12/2014) (dose not reported), subcutaneous. Concomitant therapies included atorvastatin and OMEPRAZOLE. The pharmacist reported the patient experienced redness, tenderness and swelling at the injection site after receiving ZOSTAVAX (in October 2013). The patient also received a influenza virus vaccine inactivated (unspecified) ("flu shot") on 26-SEP-2013. No treatment was given for AE. None lab diagnostics studies was performed. The patient was not recovered. The patient had sought medical attention by contacting the pharmacist. Additional information has been requested.
Age: 94.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Local swelling, Oedema peripheral
Clinical narrative: This spontaneous report was received from a registered nurse (who is reporting regarding her father) via company representative refers to a 94 year old male patient with Cardiac failure congestive. On an unknown date in NOV-2012, the patient was vaccinated with a dose of PNEUMOVAX23, (lot number, expiry date was unknown). On an unknown date in NOV-2012, the patients arm developed cellulitis, edema and was swollen. Ice pack was rendered as a treatment for the events. The events lasted for 5 days. The outcome of the events were reported as recovered. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from an unknown reporter refers to a patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II (lot # H020255, expiry date: 08-NOV-2014, therapy type, dose, route were unknown), which was improperly stored vaccine. This is one of several reports that received from the same source. Additional information is not expected.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a Company Representative via the physician refers to an approximately 62 years old male patient. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, lot number and expiration date not provided). On an unknown date in September 2013 the patient experienced shingles. At the time of this report the patient was recovering from the event of shingles. The patient sought medical attention by the office visit. The relatedness between shingles and the vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse refers to a 30 year old female patient. On 29-OCT-2013, the patient was vaccinated with an expired dose of M-M-R II (lot # 671552/1542AA, expiry: 30-SEP-2013), 0.5 ml, subcutaneously. On 29-OCT-2013, the patient experienced patient was administered an expired dose of M-M-R II. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age. On 17-OCT-2013, the patient was vaccinated inadvertently with an expired dose of 0.5ml PNEUMOVAX23, (lot number 1477AA, expiry date 14-MAY-2013). No adverse effects reported. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 76 year old male consumer with no drug reactions or allergies refers to himself. In 2010(3 years ago) the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose and route not reported). No concomitant medication was reported. The patient reported that he had developed the shingles twice since receiving ZOSTAVAX. The date that the patient experienced each case of the shingles was unspecified. The patient was currently taking valacyclovir hydrochloride 1 gram/ taken 3 times daily to treat his second occurrence of shingles which was still ongoing. None lab diagnostics studies was performed. The patient had sought medical attention. Additional information is not expected.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Electrocardiogram normal, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 22 October 2013. A 21-year-old male subject with no reported past medical history had received an injection of ACAM2000 (lot number, route and site not reported), an injection of Anthrax Vaccine (manufacturer, lot number, route and site not reported) and an injection of Typhoid Vaccine (manufacturer, lot number, route and site not reported) on 10 January 2011. Eight days later on 18 January 2011, the subject had an elevated Troponin I level of 0.12 ng/mL. Troponin I recheck on 20 January 2011 was <0.10 ng/mL and ECG was normal. The subject was asymptomatic. Outcome was recovered on 20 January 2011. According to the Investigator, the event of elevated troponin was considered an important event and possibly related. 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: 20.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Electrocardiogram abnormal, Supraventricular extrasystoles, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 22 October 2013. A 20 year-old female subject with a past medical history of chest wall pain since December 2009 was found to have on 15 December 2010 an abnormal ECG seven days after the subject had received on 08 December 2010 the following vaccines: ACAM2000 (lot number, route and site of administration not reported) and Anthrax vaccine (manufacturer, lot number, route and site of administration not reported). On 15 December 2010, the subject's ECG which was performed in error was abnormal with ectopic supraventricular rhythm. Troponin level was normal at < 0.10 ng/ml on 15 December 2010. The subject had no new chest pain or cardiac symptoms. No further information was available at the time of the report. The subject's outcome was still present, no treatment (not recovered). Per the Investigator, the event of abnormal ECG was mild in severity and possibly related to vaccination. This represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: none.
Age: 37.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Electrocardiogram normal, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 22 October 2013. A 37-year-old male subject with no reported past medical history had received an injection of ACAM2000 (lot number, route and site not reported) and an injection of Anthrax Vaccine (manufacturer, lot number, route and site not reported) on 09 August 2011. Ten days later on 19 August 2011, the subject had an elevated Troponin I level of 0.14 ng/mL. Troponin I recheck on 22 August 2011 was <0.10 ng/mL and ECG was normal. The subject was asymptomatic and referred appropriately but results were not available. Outcome was recovered on 22 August 2011. According to the Investigator, the event of elevated troponin was considered an important event and possibly related. 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: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Heart rate increased, Respiratory disorder
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 79 year old female patient with no pertinent medical history. On 03-NOV-2013, the patient was vaccinated with a single standard dose of ZOSTAVAX, subcutaneous (lot # and site of administration not reported). On 06-NOV-2013, 4 days after vaccination the patient experienced increased heartbeat, unspecified changes in her breathing and weakness. The patient went for an office visit with the physician. The outcome of increased heartbeat, unspecified changes in her breathing and weakness was reported as recovering/resolving. The relatedness between ZOSTAVAX and adverse events was not reported. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Dizziness, Dyspnoea, Heart rate increased, Visual impairment
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 79 year old female patient with no pertinent medical history. On 03-NOV-2013, the patient was vaccinated with a single standard dose of ZOSTAVAX, subcutaneous (lot # and site of administration not reported). On 06-NOV-2013, 4 days after vaccination the patient experienced increased heartbeat, unspecified changes in her breathing and weakness. The patient went for an office visit with the physician. The outcome of increased heartbeat, unspecified changes in her breathing and weakness was reported as recovering/resolving. The relatedness between ZOSTAVAX and adverse events was not reported. Additional information has been requested.
Sex: U
Vaccine: FLU3
Symptoms: Injection site cellulitis, Injection site nodule, Injection site swelling
Clinical narrative: Initial report was received from a healthcare professional on 16 September 2013. This case involves a cluster of three unidentified patients who experienced adverse events following FLUZONE administration. Three unidentified patients received a dose of FLUZONE (Sanofi Pasteur; lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced reactions of swelling, knot and cellulitis at the injection site. No additional information was provided. Outcome was unknown. Documents held by sender: None. Follow-up information received from a healthcare professional on 24 October 2013: The reporter stated that she did not have any patient information or vaccine details. She heard from Employee Health and thought patients were all employees.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Vocational Nurse refers to unspecified number of patients of unknown age and gender. It was reported that unspecified number of doses of GARDASIL was exposed to a total of 72 hours with a highest temperature of 57F. These doses were administered to an unspecified number of patients on unspecified dates (doses, routes and lot # not reported). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 15-OCT-2013 the patient was vaccinated with PNEUMOVAX23 intramuscularly (lot # J000388 exp. date: 06-AUG-2014, dose, strength, site of administration not reported). The reporter stated that PNEUMOVAX23 was exposed to -2.8C for 68 hours with the vaccine possibly going above and below 0'C more than two times during this excursion. No adverse effect reported. This is one of two reports from the same reporter (MARRS case # 1311USA001488). Additional information has been requested.
Age: 35.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Malaise, Pain
Clinical narrative: This spontaneous report as received from a 35 year old male patient reporting himself. The patient's medical history included serious car accident, surgery (not specified) and no known allergies. On 21-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX at a pharmacy (lot number, expiry date, dose and route unspecified). Concomitant therapies included acetaminophen, NORCO, meloxicam, SOMA, KLONOPIN and gabapentin. On 21-OCT-2013, the patient experienced redness, pain and malaise after receiving the ZOSTAVAX. The patient had not sought medical attention. The outcome of adverse events was unknown. The causality between adverse events and ZOSTAVAX was not provided. Additional information has been requested.
Age: 0.67
Sex: M
Vaccine: FLU4
Symptoms: Blood test, Febrile convulsion, Pyrexia, Urine analysis, X-ray
Clinical narrative: Febrile seizure. Taken by ambulance to hospital. Fever measured at 105.5 rectally at hospital.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Hypoaesthesia oral
Clinical narrative: AFTER RECEIVING THE FLU SHOT THE PATIENT STARTED HAVING NUMBNESS OF THE MANDIBLE, MOUTH AND TONGUE, AFTERWARD WITH HEADACHE.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Limb discomfort
Clinical narrative: Pt states arm discomfort after receiving flu shot 10/10/13, radiating down to fingers.  Denies redness or swelling at the site.  Advised to contact physician or visit to rule out any other condition.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: The site swelled up in size, became hard and red and hot to touch. Area of swollen red, hot bullseye was 5mm top to bottom and 8 mm across.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema, Pyrexia, Upper respiratory tract infection, Urticaria
Clinical narrative: Broke out in hives and developed an upper respiratory tract infection within 24 hours after injection. Injection site on arm was red and hives on upper torso and arms. Went to local walk in clinic. They gave me Prednisone and a steroid shot for the hives. Went back in on Monday 11/4/2013 as the upper respiratory tract infection had gotten much worse along with a fever. The walk in clinic PA gave me another Prednisone shot and a breathing treatment. Also prescribed an albuterol inhaler as well as prednisone pills and Zpack. Today is 11/8/2013 and still have the upper respiratory tract infection but does appear to be getting better.
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Chest pain, Dizziness, Dyspnoea, Feeling abnormal, Headache
Clinical narrative: Nausea and headache at 12:00 Dizzy,headache,shaky, itchy,difficulty breathing, pain in the chest, and out of body feeling starting at 3:00 PM
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Nausea, Pruritus, Tremor
Clinical narrative: Nausea and headache at 12:00 Dizzy,headache,shaky, itchy,difficulty breathing, pain in the chest, and out of body feeling starting at 3:00 PM
Age: 79.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Musculoskeletal chest pain, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Back stiff, severe pain in the center of back to the neck, expanded to front and back rib cage and right back should blade area. Continued for 4+ weeks.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Biopsy skin, Rash generalised
Clinical narrative: Severe rash all over entire body.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Lip swelling
Clinical narrative: Difficulty breathing and swelling of lips. She used her inhaler and took Benadryl 50mg PO.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: First reaction was large painful swelling at injection site. Next day injection site was red feverish and itchy, I felt achy.  Seven days later my right hip began to hurt in the same location where I had suffered shingles in 2009.  Shingles in 2009 were in right leg quadrant.  Pain is nearly as bad as shingles attack.  Require pain-killer to sleep and have painful difficulty rising from a prone position. Feels like shingles again but without the blisters. Not sure how long this will continue.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Insomnia, Mobility decreased, Pain
Clinical narrative: First reaction was large painful swelling at injection site. Next day injection site was red feverish and itchy, I felt achy.  Seven days later my right hip began to hurt in the same location where I had suffered shingles in 2009.  Shingles in 2009 were in right leg quadrant.  Pain is nearly as bad as shingles attack.  Require pain-killer to sleep and have painful difficulty rising from a prone position. Feels like shingles again but without the blisters. Not sure how long this will continue.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Vocational Nurse refers to unspecified number of patients of unknown age and gender. It was reported that unspecified number of doses of PEDVAXHIB were exposed to a total of 72 hours with a highest temperature of 57F. These doses were adminstered to an unspecified number of patients on unspecified dates (doses, routes and lot # not reported). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: 14 x 14 cm red, tender, warm area around vaccine site. Determined to be larger than normal local reaction. No treatment other than ibuprofen and BENADRYL recommended.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 55 years old male patient with none pertinent medical history or drug reactions/allergies. On 07-AUG-2012 the patient was vaccinated with ZOSTAVAX (lot # 0365AE, exp. date. 23-APR-2013, 0.65 ml, once, subcutaneous) because of doctor recommendation. Concomitant therapies included LIPITOR. On approximately 28-AUG-2013 (reported as about 3 weeks after receiving ZOSTAVAX) the patient experienced shingles-like rash. The patient did not seek any medical attention in regards to the reaction. No treatment given. The shingles-like rash cleared up a couple days later, on an unknown date in 2013. The patient did not seek medical attention, no treatment was given for shingles-like rash and none lab diagnostic tests were performed. The relatedness between ZOSTAVAX and shingles-like rash was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (a pharmacy buyer) refers to a patient of unknown age and gender. On 07-NOV-2013 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # J001729, expiration date: 20-OCT-2013, 0.65 ml, subcutaneously). No symptoms were reported. Additional information is not expected.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Shoulder pain since 10/16/2013 since flu shot administered.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Chills, Pain in extremity
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 59 year old female patient. The patient has morphine allergy, penicillin allergy, iodine allergy, latex - unspecified allergies and sulfa allergy. On 29-OCT-2013, the patient was vaccinated with a 0.5 ml of PNEUMOVAX23 (lot # J004196, expiry date 06-DEC-2014, route was subcutaneous). Concomitant medications were none. On 29-OCT-2013, the patient experienced burning pain of her left arm and chills two hours after receiving PNEUMOVAX23. The patient sought medical attention. On 31-OCT-2013, the patient saw the physician in the office and was treated with KEFLEX. Patient received treatment with antibiotics and KEFLEX (500 mg/three times a day/for 10 days). Later the patient was admitted to the hospital for pain and cellulitis. The outcome of the events were unknown. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain, swelling, redness, and warmth at injection site. Stated swelling was size of grapefruit 11-6-13. Area improved 11-8-13.
Age: 60.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Contusion, Discomfort, Myalgia, Pain in extremity
Clinical narrative: Muscle soreness, no redness, painful when lifts weighted stuff. Has used TYLENOL for discomfort started joint after received injection. States is getting better slowly. Back in dr 11-5-13. Bruising on arm now.
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose increased, Pyrexia
Clinical narrative: Resident was given a flu shot by home care RN. That night he had a fever which increased his BS to 160. The next am his blood sugar was 197 at 7 am, 199 at 11 am, and 4 pm 159 blood sugar. MD increased HUMALOG by 8 units. FBS on 10/24 = 136 mg/d FBS 10/25 = 145 mg/dl FBS 10/26 = decreased 100 back to usual BS range by 10/26/2013.
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Apnoea
Clinical narrative: 37 hrs after receiving PEDIARIX infant was apneic requiring PPV - increase in periodic breathing and desaturations.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal X-ray, Abdominal pain, Haematochezia, Occult blood positive, X-ray abnormal
Clinical narrative: Possible intussusception. Abdominal pain/blood in stool. Abnormal x-ray. Resolved on own.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Pyrexia
Clinical narrative: Fever, upper arm redness and warmth, instructed to use cold compress and take BENADRYL BID.
Age: 27.0
Sex: M
Vaccine: FLUN4
Symptoms: Urticaria
Clinical narrative: Acute hives. Pt was treated in local hospital with BENADRYL and 0.3 mg/0.3 mL EPIPEN injectable.
Age: 31.0
Sex: U
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: FLUZONE Sanofi Pasteur administered into (R) deltoid within 5 mins the individual experienced intermittent hand and arm tremors for 24 hours.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patients left deltoid was swelled up 4" in diameter and 1/2" high. Redness, itching, hot to touch, w/no fever.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Pain in extremity, Skin warm, Tenderness
Clinical narrative: 6 hrs after vaccination arm began to feel sore and over next few hours, became swollen, red, warm and more tender.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Arm pain at injection site. Treatment from MD was cold compress and NSAIDs. Arm pain began day after injection.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence, Swelling, Vomiting
Clinical narrative: 10/31 Day 1 - threw up (vomiting), drowsy, swollen, line going toward heart. 11/1 Day 2 - Saw Dr. and gave her levothyroxine and going back for follow up 11/4.
Age: 85.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Back pain, Muscular weakness, Pyrexia
Clinical narrative: Severe fever that lasted 18 hours, along with muscle and joint weakness that lasted for 10 days. Also lower back pain, I took ALEVE 200 mg, 2 per day until the symptoms went away.
Age: 12.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Cough, Fatigue, Lacrimation increased, Local swelling, Rash
Clinical narrative: While waiting in office following vaccines, he developed a cough, watery eyes and a red blotchy rash to his chest with some swelling of the left hand.  His exam was otherwise normal, with no difficulty swallowing and no wheezing.  O2 was 100%.  He was given 25 mg of Benadryl and calmed down, but kept with cough and tiredness.
Age: 12.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Rash erythematous, Rash macular
Clinical narrative: While waiting in office following vaccines, he developed a cough, watery eyes and a red blotchy rash to his chest with some swelling of the left hand.  His exam was otherwise normal, with no difficulty swallowing and no wheezing.  O2 was 100%.  He was given 25 mg of Benadryl and calmed down, but kept with cough and tiredness.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Acoustic neuroma, Deafness neurosensory, Ear congestion, Influenza like illness, Tinnitus
Clinical narrative: 10-15 felt fullness in left ear-went to PMD-thought to have been wax in ear. 10-16 &17 flulike symptoms with vertigo. 10-17 felt better but had ringing in left ear-referred to ENT. 10-30 ENT= profound sensorineural hearing loss treated with steroids and ordered MRI r/o acoustic neuroma. 11-7 Second opinion sensorineural hearing loss after flu shot.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Vaccination complication, Vertigo
Clinical narrative: 10-15 felt fullness in left ear-went to PMD-thought to have been wax in ear. 10-16 &17 flulike symptoms with vertigo. 10-17 felt better but had ringing in left ear-referred to ENT. 10-30 ENT= profound sensorineural hearing loss treated with steroids and ordered MRI r/o acoustic neuroma. 11-7 Second opinion sensorineural hearing loss after flu shot.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling
Clinical narrative: LOCALIZED SWELLING. ICE TO SITE, MONITORED VITAL SIGNS.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Biopsy, Chest X-ray, Endotracheal intubation, Feeling hot, Lymph node pain
Clinical narrative: In neck same side as arm injection site two lymph nodes became hot, painful, and then massively swollen.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy, Rectal examination, Tumour marker test, Ultrasound scan
Clinical narrative: In neck same side as arm injection site two lymph nodes became hot, painful, and then massively swollen.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Back pain, Contusion, Culture, Culture urine, Fungal infection
Clinical narrative: burning and itchy vagina-treated for UTI although test was negative,also treated for yeast infection and is still present, headaches, blurred vision, back pain on right side-kidney ultrasound negative, swollen lymph nodes in groin painful and bruised size of golfballs
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Headache, Lymph node pain, Lymphadenopathy, Ultrasound kidney normal, Urinary tract infection
Clinical narrative: burning and itchy vagina-treated for UTI although test was negative,also treated for yeast infection and is still present, headaches, blurred vision, back pain on right side-kidney ultrasound negative, swollen lymph nodes in groin painful and bruised size of golfballs
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Vision blurred, Vulvovaginal burning sensation, Vulvovaginal pruritus
Clinical narrative: burning and itchy vagina-treated for UTI although test was negative,also treated for yeast infection and is still present, headaches, blurred vision, back pain on right side-kidney ultrasound negative, swollen lymph nodes in groin painful and bruised size of golfballs
Age: 14.0
Sex: F
Vaccine: FLUX, HEPA, MEN
Symptoms: Abnormal behaviour, Aggression, Anger
Clinical narrative: SHE WAS IRATE! MY DAUGHTER IS VERY SHY, RESERVED, QUIET! SHE IS AN HONOR STUDENT! NOT IN HER CHARACTER AT ALL!!!! SHE WAS NOT HERSELF!! SHE WAS PHYSICAL LAST NIGHT W ME AND MY BF! SHE WOULD NEVER EVER LIFT A FINGER TO ANYONE!!!!! SHE WAS JUST SO IRATE AND FROM WHAT I COULD SEE SHE WAS NOT HERSELF SHE HAD A LOOK IN HER EYE I HAVE NEVER SEEN!! I DO NOT BELIEVE SHE KNEW WHAT SHE WAS DOING!! I PERSONALLY THINK IT WAS TO MANY SHOTS FOR SOMEONE WITH HER HISTORY OF ASTHMA AND ALLERGIES!!! SHE WAS NOT HERSELF!!!!!!!!! IT WAS MORE THAN A MILD IRRITABILITY LIKE THE SIDE EFFECTS SAY!!!!!
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: miscarriage after vaccination