chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Blood glucose normal, Convulsion, Dizziness, Electrocardiogram normal, Immediate post-injection reaction
Clinical narrative: Case number PHHY2013US097420, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: A94886) website on 05 Sep 2013 with the follow-up received from QA department (reference number: 251975) on 17 Oct 2013. This report refers to an 18-year-old female patient. She had no known drug allergies in the past. Concomitant drugs included ZOVIA and Multigen plus. She was vaccinated with MENVEO (batch number: A11046) in the left arm on 21 Jun 2013. On the same date, immediately after vaccination the patient became light headed/dizzy. She then started to seize for less than a minute and emergency service was called. Her blood pressure was 107/85. She was then nauseous. Her blood sugar (96, units not provided), heart rate (22 later 50, units not provided), respiratory rate (16, units not provided) and 12 lead heart tests (normal) were done. It was reported that the patient would see the doctor soon. The outcome of the events was reported as not recovered as of 21 Jun 2013. The seriousness and causality of the events were not reported. Based on the batch review, it was stated that the concerned MENVEO, batch number (A11046) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practice (cGMP) requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 251975) on 12 Sep 2013: Updated QA reference number only. Follow-up received from QA department on 17 Oct 2013: Batch review report updated
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Nausea
Clinical narrative: Case number PHHY2013US097420, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: A94886) website on 05 Sep 2013 with the follow-up received from QA department (reference number: 251975) on 17 Oct 2013. This report refers to an 18-year-old female patient. She had no known drug allergies in the past. Concomitant drugs included ZOVIA and Multigen plus. She was vaccinated with MENVEO (batch number: A11046) in the left arm on 21 Jun 2013. On the same date, immediately after vaccination the patient became light headed/dizzy. She then started to seize for less than a minute and emergency service was called. Her blood pressure was 107/85. She was then nauseous. Her blood sugar (96, units not provided), heart rate (22 later 50, units not provided), respiratory rate (16, units not provided) and 12 lead heart tests (normal) were done. It was reported that the patient would see the doctor soon. The outcome of the events was reported as not recovered as of 21 Jun 2013. The seriousness and causality of the events were not reported. Based on the batch review, it was stated that the concerned MENVEO, batch number (A11046) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practice (cGMP) requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 251975) on 12 Sep 2013: Updated QA reference number only. Follow-up received from QA department on 17 Oct 2013: Batch review report updated
Age: 44.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site pain, Insomnia, Muscular weakness
Clinical narrative: Severe pain and immobility of shoulder since the day after the flu shot.
Age: 44.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Severe pain and immobility of shoulder since the day after the flu shot.
Age: 13.0
Sex: M
Vaccine: FLUN4, HPV4, FLUN4, HPVX, HPV4
Symptoms: Convulsion, Seizure like phenomena
Clinical narrative: A report has been received from a health professional (registered nurse) concerning a 13 year old male patient. No information regarding relevant medical history, concomitant disease, or concomitant medication was provided. Nurse reported that two teenagers received FLUMIST QUAD and HPV vaccine yesterday, and 5 minutes after receiving them, both patients had a seizure for 45 seconds. When they came out of the seizure both patients were very agitated and swinging at the air for a few minutes. They have removed all FLUMIST QUAD from the floor. The outcome of the event of patient experienced seizure after 5 minutes of receiving FLUMIST quadrivalent was unknown. The reporter assessed the event of patient experienced seizure after 5 minutes of receiving FLUMIST quadrivalent to be serious with seriousness criteria of important medical event.
Age: 13.0
Sex: M
Vaccine: FLUN4, HPV4, FLUN4, HPVX, HPV4
Symptoms: Agitation, Convulsion
Clinical narrative: A report has been received from a health professional (registered nurse) concerning a 13 year old male patient. No information regarding relevant medical history, concomitant disease, or concomitant medication was provided. Nurse reported that two teenagers received FLUMIST QUAD and HPV vaccine yesterday, and 5 minutes after receiving them, both patients had a seizure for 45 seconds. When they came out of the seizure both patients were very agitated and swinging at the air for a few minutes. They have removed all FLUMIST QUAD from the floor. The outcome of the event of patient experienced seizure after 5 minutes of receiving FLUMIST quadrivalent was unknown. The reporter assessed the event of patient experienced seizure after 5 minutes of receiving FLUMIST quadrivalent to be serious with seriousness criteria of important medical event.
Age: 13.0
Sex: M
Vaccine: FLUN4, HPV4, FLUN4, HPVX, HPV4
Symptoms: Agitation, Incoherent, Pallor, Seizure like phenomena
Clinical narrative: A report has been received from a health professional (registered nurse) concerning a 13 year old male patient. No information regarding relevant medical history, concomitant disease, or concomitant medication was provided. Nurse reported that two teenagers received FLUMIST QUAD and HPV vaccine yesterday, and 5 minutes after receiving them, both patients had a seizure for 45 seconds. When they came out of the seizure both patients were very agitated and swinging at the air for a few minutes. They have removed all FLUMIST QUAD from the floor. The outcome of the event of patient experienced seizure after 5 minutes of receiving FLUMIST quadrivalent was unknown. The reporter assessed the event of patient experienced seizure after 5 minutes of receiving FLUMIST quadrivalent to be serious with seriousness criteria of important medical event.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Abnormal behaviour, Computerised tomogram normal, Convulsion, Dyspnoea, Fatigue
Clinical narrative: Seen in Hospital ED - transferred to another hospital. Admitted 10/11/13/Discharged 10/20/13. Dx = muscle spasms of back, opisthotonus, dystonia, axial. Not felt to be vaccine related.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Gaze palsy, Intensive care, Laboratory test, Musculoskeletal stiffness, Palpitations
Clinical narrative: Seen in Hospital ED - transferred to another hospital. Admitted 10/11/13/Discharged 10/20/13. Dx = muscle spasms of back, opisthotonus, dystonia, axial. Not felt to be vaccine related.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Swelling face, Syncope
Clinical narrative: Seen in Hospital ED - transferred to another hospital. Admitted 10/11/13/Discharged 10/20/13. Dx = muscle spasms of back, opisthotonus, dystonia, axial. Not felt to be vaccine related.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Anti-GAD antibody, Antibody test, Blood creatine phosphokinase, Borrelia test, Computerised tomogram
Clinical narrative: Seen in Hospital ED - transferred to another hospital. Admitted 10/11/13/Discharged 10/20/13. Dx = muscle spasms of back, opisthotonus, dystonia, axial. Not felt to be vaccine related.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Dystonia, Herpes simplex serology, Laboratory test, Muscle spasms, Nuclear magnetic resonance imaging
Clinical narrative: Seen in Hospital ED - transferred to another hospital. Admitted 10/11/13/Discharged 10/20/13. Dx = muscle spasms of back, opisthotonus, dystonia, axial. Not felt to be vaccine related.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Opisthotonus, Streptococcus test, Thyroid function test, X-ray
Clinical narrative: Seen in Hospital ED - transferred to another hospital. Admitted 10/11/13/Discharged 10/20/13. Dx = muscle spasms of back, opisthotonus, dystonia, axial. Not felt to be vaccine related.
Age: 81.0
Sex: F
Vaccine: FLUX, VARZOS, FLU3, VARZOS
Symptoms: Rash
Clinical narrative: Pt developed rash on 10/27/13 after ZOSTAVAX and FLUVIRIN admin 10/24/2013.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5
Symptoms: Ileus, Ultrasound abdomen, Urinary system X-ray, Vomiting
Clinical narrative: This spontaneous report as received from a physician refers to a 4 months old patient of unknown gender. On an unknown date, the patient was vaccinated with a dose of ROTATEQ (Lot number, expiry date, route and dose were not reported) at the age of 2 months old and then at the age of 4 months old. On an unknown date, after the dose of ROTATEQ was administered to the patient at the age of 4 months old, the patient developed "extreme" vomiting and was admitted to an unspecified hospital on an unspecified date with an ileus. The outcome of ileus and vomiting was unknown. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5
Symptoms: Ileus, Vomiting
Clinical narrative: This spontaneous report as received from a physician refers to a 4 months old patient of unknown gender. On an unknown date, the patient was vaccinated with a dose of ROTATEQ (Lot number, expiry date, route and dose were not reported) at the age of 2 months old and then at the age of 4 months old. On an unknown date, after the dose of ROTATEQ was administered to the patient at the age of 4 months old, the patient developed "extreme" vomiting and was admitted to an unspecified hospital on an unspecified date with an ileus. The outcome of ileus and vomiting was unknown. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: MEN
Symptoms: Back pain, Burning sensation, Diarrhoea, Hypoaesthesia, Nervous system disorder
Clinical narrative: Ten days after vaccine administration developed diarrhea (lasted 2 days) with extreme lower back pain (lasted 2 weeks). Six months after the vaccine administration lower back pain and burning sensation in the sole of feet along with a sensation of numbness in the fingers of hands. Pain subsided after 2 days. Currently burning sensation in the soles of feet comes and goes from time to time. Feels like something is wrong with nerves in the hands and feet.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial neuralgia, Facial pain, Injection site rash, Mass, Pain in extremity
Clinical narrative: Egg sizes lump.  Warm to touch.  Ache in my arm from my armpit to my elbow.  Bumpy skin at the site. For about a week.  Two weeks later developed neuralgia in my face on the same side as the shot.  Diagnosed by a neurologist as A typical face pain.  On going.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Egg sizes lump.  Warm to touch.  Ache in my arm from my armpit to my elbow.  Bumpy skin at the site. For about a week.  Two weeks later developed neuralgia in my face on the same side as the shot.  Diagnosed by a neurologist as A typical face pain.  On going.
Age: 0.3
Sex: F
Vaccine: HIBV, PPV
Symptoms: Crying, Pain, Vaccination site pain, Vomiting
Clinical narrative: Within a couple of hours of vaccination, she started crying and vomited several times. On evaluation, she was felt to have unusually tender thigh where vaccine had been administered. Following APAP administration, she was consolable, until moved or manipulated, especially by lower extremities.
Age: 5.0
Sex: M
Vaccine: HEP
Symptoms: Allergy test, Alopecia, Antibody test, Blood lead, Eczema
Clinical narrative: This spontaneous report was received from a physician via company representative refers to an approximately 5year old male patient. The patient has seasonal allergies, the patient had no drug allergies and he was currently allergic to cashews. The patient was previously allergic to eggs and to cats but outgrew these allergies. On an unknown date in 2007 (reported as at birth) the patient was vaccinated with first dose of RECOMBIVAX HG (lot number, expiry date and route was unknown). On an unknown date, the patient was vaccinated with second dose of RECOMBIVAX HB (lot number, expiry date and route was unknown). Concomitant therapies included CLARITIN. Approximately on an unknown date in 2013, the patient experienced eczema and alopecia. The office manager first noticed a patch of missing hair on her sons scalp in July 2012 when he had a haircut. She stated that her son used to have thick curly hair. However currently he has no hair on head and body including no eyebrows. He went to the doctor who diagnosed him with tinea capitis and was treated with griseofulvin which did not help. He then switched to another physician who treated him with an unspecified antifungal cream which did not help. He then switched to another physician who said that tine capitis was a misdiagnosis. She then diagnosed him with alopecia and eczema. The patient was prescribed with Retin A and Rogaine as a treatment. The patient tried for a month and discontinued them because they did not help. Antibody testing, gluten testing and lead poisoning testing was performed. The outcome of the events were reported as not recovered. The patient sought medical attention. This is one of the two reports received from the same reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from another health professional refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. It was reported that on 03-SEP-2013, GARDASIL went out of range as it was exposed to 31.2 F for 6 hours. On 27-SEP-2013, the patient was administered with this improperly stored GARDASIL (route of administration unknown) for an unknown indication. Lot number was reported as H021861 with an expiration date of 09-OCT-2015. No adverse effects were reported. No further information was provided. This is one of 16 reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea
Clinical narrative: This spontaneous report was received from an unknown age female patient reporting on herself. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with PENUMOVAX23 (dose and lot number were not reported). Concomitant medication was not reported. On an unknown date, after receiving PNEUMOVAX23, the patient experienced extreme diarrhea. The outcome of experiencing extreme diarrhea was unknown. Causality was not reported. Additional information is not expected.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Joint range of motion decreased, Pain
Clinical narrative: Pain in left after flu shot - unable to move left arm for couple of days - Got little better - but unable to do range of motion.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from another health professional refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. It was reported that on 03-SEP-2013, GARDASIL went out of range as it was exposed to 31.2 F for 6 hours. On 26-SEP-2013, the patient was administered with this improperly stored GARDASIL (route of administration unknown) for an unknown indication. Lot number was reported as H021861 with an expiration date of 09-OCT-2015. No adverse effects were reported. No further information was provided. This is one of 16 reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: FLU3
Symptoms: Fatigue, Feeling abnormal, Pain in extremity
Clinical narrative: Awoke 10/30/13 tired, achy legs, feels "out of it." No rashes. No inflammation at vaccine site. No diff breathing swallowing. T - 98.7.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Condition aggravated, Convulsion
Clinical narrative: Pt stated the next day after the Flu shot pt had a seizure - called MD but has underlying seizure disorder.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Muscular weakness, Neuromyelitis optica, Paraesthesia
Clinical narrative: Patient had MENACTRA on 6/11/13. Developed complaints of leg and arm weakness, tingling first week of August 2013. Diagnosed with neuromyelitis optica in mid August, between 8/16 and 8/20/13.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Disorientation, Dizziness, Feeling hot, Headache
Clinical narrative: This spontaneous report was received from an 80 year old female consumer who was conferenced in by the Medical Team refers to herself. On 07-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX injection (lot#, expiration date, dose and frequency not reported) subcutaneous for preventions of shingles. Concomitant medication included unspecified generic blood pressure medicine. On Monday, 07-OCT-2013, she had been administered ZOSTAVAX, immediately she experienced a pronounced headache, "similar to an ice cream headache." The headache had continued throughout the following days, accompanied by disorientation, chills, faintness, intermittent warmth and lightheadedness. The patient note that she would like to visit her physician in response to these flu-like symptoms but "is afraid to drive," due to the lightheaded feeling and dizziness. So she did not seek medical attention. She was given treatment for adverse events, using Motrin (OTC product). The adverse events were not improved. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Impaired driving ability, Influenza like illness
Clinical narrative: This spontaneous report was received from an 80 year old female consumer who was conferenced in by the Medical Team refers to herself. On 07-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX injection (lot#, expiration date, dose and frequency not reported) subcutaneous for preventions of shingles. Concomitant medication included unspecified generic blood pressure medicine. On Monday, 07-OCT-2013, she had been administered ZOSTAVAX, immediately she experienced a pronounced headache, "similar to an ice cream headache." The headache had continued throughout the following days, accompanied by disorientation, chills, faintness, intermittent warmth and lightheadedness. The patient note that she would like to visit her physician in response to these flu-like symptoms but "is afraid to drive," due to the lightheaded feeling and dizziness. So she did not seek medical attention. She was given treatment for adverse events, using Motrin (OTC product). The adverse events were not improved. Additional information has been requested.
Age: 1.11
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash maculo-papular, Rash vesicular, Skin lesion
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 1 year old male patient. None pertinent medical history, drug reactions or allergies were reported. On 27-AUG-2013, the patient was vaccinated with VARIVAX first dose, 0.5 ml, subcutaneous, lot # J001648, expiration date: 11-FEB-2015. None concomitant medication was reported. On 06-SEP-2013, 10 days after administration of VARIVAX, the patient developed a 102 Fahrenheit fever. On 18-SEP-2012, 22 days after vaccination, the patient developed a widespread, varicella-like rash with greater than 50 lesions. Some lesions were maculo-papular, and a few lesions were vesicular. The patient sought medical attention by attending an office visit and was treated with Tylenol and calamine lotion topically. On an unknown day in September 2013, isolates of the lesions were sent to the Center for Disease Control and Prevention (CDC) for investigation and the results were negative to varicella. On 25-SEP-2013, the patient was examines and the lesions were "scabbed over", on the same date the patient was reported as recovered. Causality was not reported. Additional information has been requested.
Age: 1.98
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 2 year old female patient. Medical history was not provided. On 12-AUG-2010 the patient was vaccinated with VARIVAX (Merck) lot number 666702/0026Z with expiration date 22-DEC-2011) dose 1. Concomitant medication was not provided. 3 months after the first dose of VARIVAX (Merck) (estimated as November 2010) the patient experienced chickenpox. The outcome of chickenpox was unknown. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 70 year old female patient with prednisone allergy, codeine allergy and morphine allergy. The patient's medical history included breast cancer of left side and nodes removed. On 23-AUG-2012 the patient was vaccinated with a first dose of PNEUMOVAX23 (lot number, dose and route of administration were not reported) in the right arm. On 03-OCT-2013 the patient was vaccinated with the second dose of PNEUMOVAX23 (lot number, dose and route of administration were not reported) in the right arm. On 04-OCT-2013 the patient was presented at the Emergency Room (ER) injection site reactions of right arm. Redness, hot, swelling tracking up to the right axilla down to the right forearm. The patient sought medical attention via Emergency Room (ER) visit. The patient did not recover from adverse events. The relatedness between vaccination with PNEUMOVAX23 and adverse events was not reported. Additional information has been requested.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a 63 year old consumer of unknown gender refers to himself/herself (weight 160 unit not provided). On 14-OCT-2013 the patient was vaccinated with ZOSTAVAX (dose, frequency, route, lot# and expiration date unknown). Approximately in October 2013 the patient had red circle around where the injection was given, like and orange size. The patient didn't have fever and it didn't bother him/her, but it was just red. The outcome of the event was unknown. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella virus test negative
Clinical narrative: This spontaneous report as received from a physician refers to an 18 year old female patient. On an unspecified date the patient was vaccinated with a dose of VARIVAX (Merck) (lot# unspecified) dose, route and location unspecified. On an unspecified date the patient had varicella titers drawn on an unspecified date which provided "equivocal" results. At the time of report, the outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 01-OCT-2013, the patient were vaccinated with a dose of ZOSTAVAX (lot# J001694, expiration date 08-MAY-2014, dose, frequency, route and indication not reported). The vaccine was stored improperly at temperatures up to 21F from 01-JUL-2013 to 08-OCT-2013. On 08-OCT-2013, the vaccine was discarded. No adverse effects were reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 27-SEP-2013, the patient were vaccinated with a dose of ZOSTAVAX (lot# J001694, expiration date 08-MAY-2014, dose, frequency, route and indication not reported). The vaccine was stored improperly at temperatures up to 21F from 01-JUL-2013 to 08-OCT-2013. On 08-OCT-2013, the vaccine was discarded. No adverse effects were reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 10-SEP-2013, the patient were vaccinated with a dose of ZOSTAVAX (lot# J001694, expiration date 08-MAY-2014, dose, frequency, route and indication not reported). The vaccine was stored improperly at temperatures up to 21F from 01-JUL-2013 to 08-OCT-2013. On 08-OCT-2013, the vaccine was discarded. No adverse effects were reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 07-SEP-2013, the patient were vaccinated with a dose of ZOSTAVAX (lot# J001694, expiration date 08-MAY-2014, dose, frequency, route and indication not reported). The vaccine was stored improperly at temperatures up to 21F from 01-JUL-2013 to 08-OCT-2013. On 08-OCT-2013, the vaccine was discarded. No adverse effects were reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 08-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot# J001694, expiration date 08-MAY-2014, dose, frequency, route and indication not reported). The vaccine was stored improperly at temperatures up to 21F from 01-JUL-2013 to 08-OCT-2013. On 08-OCT-2013, the vaccine was discarded. No adverse effects were reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to two patients of unknown age and gender. On 18-JUL-2013, the patients were vaccinated with a dose of ZOSTAVAX (lot# J001694, expiration date 08-MAY-2014, dose, frequency, route and indication not reported). The vaccine was stored improperly at temperatures up to 21F from 01-JUL-2013 to 08-OCT-2013. On 08-OCT-2013, the vaccine was discarded. No adverse effects were reported. It was unspecified if the patients had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA, TD
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified number of patients of unknown age and gender. On an unknown date, the unspecified patients were vaccinated with a dose of tetanus and diphtheria toxoids, adsorbed (manufacturer unknown), VAQTA and RECOMBIVAX HB (lot number, expiry date, route and dose were not reported for all) that was exposed to 30 Fahrenheit for 4 days and 52 Fahrenheit for 4 days. No adverse effects reported. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Feeling abnormal, Inflammation, Injection site reaction, Nodule, Paraesthesia
Clinical narrative: 10/7-2 vaccines below received 10/8-ran high fever 103+ felt bad L arm warm and 50 cent knot reported, local inflammation with no cellulitis - She was seen urgent care and advised to take Benadryl - she also had tingling in L arm at site. Temp upper 90's rest of the week - 10/30 knot to arm still. Vomiting 10/8 x 5 - better on Thurs. 5 in family no one else sick.
Age: 26.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Pyrexia, Skin warm, Vomiting
Clinical narrative: 10/7-2 vaccines below received 10/8-ran high fever 103+ felt bad L arm warm and 50 cent knot reported, local inflammation with no cellulitis - She was seen urgent care and advised to take Benadryl - she also had tingling in L arm at site. Temp upper 90's rest of the week - 10/30 knot to arm still. Vomiting 10/8 x 5 - better on Thurs. 5 in family no one else sick.
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 a patient of unknown age and gender. Approximately on an unknown date in 2011 (reported as 2 years ago), the patient who was vaccinated with a first dose of GARDASIL may have received a second dose approximately on an unknown date in 2013 (reported as recently) (Lot number, expiry date, route and dose were not reported). No adverse effect reported was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to a patient of unknown age and gender. On 17-OCT-2013, the patient who was vaccinated with a first dose of RECOMBIVAX HB received the second dose on 21-OCT-2013 (Lot number, expiry date, route and dose were not reported for both). No adverse effects reported. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Musculoskeletal pain, Neck pain, Pain, Pyrexia
Clinical narrative: Mother of child called at 11:40 AM 10/29/13. States child had adverse reaction at 12 Noon 10/29/13 of pain radiating from L side of the neck and the shoulders/torso with 99-100 degree C fever relieved by Motrin. Advised to take child to PMD for eval.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Flushing, Migraine, Nausea, Photopsia
Clinical narrative: 30 minutes after flu vaccine, patient experienced migraine type headache with flashing lights, vision in periphery going in and out, flushing, nausea, dizziness, tachycardia.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Tachycardia, Visual field defect
Clinical narrative: 30 minutes after flu vaccine, patient experienced migraine type headache with flashing lights, vision in periphery going in and out, flushing, nausea, dizziness, tachycardia.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Flushing, Laboratory test, Migraine, Nausea
Clinical narrative: 30 minutes after flu vaccine, patient experienced migraine type headache with flashing lights, vision in periphery going in and out, flushing, nausea, dizziness, tachycardia.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Photopsia, Tachycardia, Visual field defect
Clinical narrative: 30 minutes after flu vaccine, patient experienced migraine type headache with flashing lights, vision in periphery going in and out, flushing, nausea, dizziness, tachycardia.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dysgeusia, Exposure during pregnancy, Injection site warmth, Throat irritation
Clinical narrative: Received vaccine approx. 12:30 PM. Developed "hot" feeling at injection site, developed throat clearing symptoms, metallic taste, chest tightness toward throat. Taken to health urgent care onsite, observed 15 min and transferred and was administered Claritin and observed for 3 hours.  10/31 - Instructed by ED physician and OB/GYN not to take influenza vaccine again.
Age: 3.0
Sex: M
Vaccine: FLUX
Symptoms: Dysphemia
Clinical narrative: Stuttering.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Headache, Neck pain, Pain, Tenderness
Clinical narrative: Ache to both sides of neck and the right side of the back of head.  Hurts to move head at night.  Pain in head and neck upon touch and when coughing.  Ache and pain minimally relieved by ibuprofen but getting better after 2 weeks.
Age: 29.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Pain, Rash, Rash erythematous
Clinical narrative: Worked nocs so came home and slept when awoke congested, achy, dizzy and weak. Awake Sat evening small red itchy rash on R arm. Throughout the night shift rash spread all the way down the R arm onto head. Left arm and both legs. No improvement on Sunday. Went to urgent care on Monday.
Age: 29.0
Sex: M
Vaccine: FLU4
Symptoms: Rash pruritic, Respiratory tract congestion
Clinical narrative: Worked nocs so came home and slept when awoke congested, achy, dizzy and weak. Awake Sat evening small red itchy rash on R arm. Throughout the night shift rash spread all the way down the R arm onto head. Left arm and both legs. No improvement on Sunday. Went to urgent care on Monday.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Muscular weakness, Nausea, Vomiting
Clinical narrative: Nausea, diarrhea, vomiting, leg weakness.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Muscle aches, fever, headaches, right arm pain at injection sites.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Balance disorder, Erythema, Headache, Photopsia, Pyrexia
Clinical narrative: Patient states: "I am experiencing strong headaches, fever, hot ear with redness, constant flashes of light and unbalance."
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Skin warm
Clinical narrative: Patient states: "I am experiencing strong headaches, fever, hot ear with redness, constant flashes of light and unbalance."
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Asthenia, Burning sensation, Myalgia, Pain in extremity
Clinical narrative: Severe weakness, muscle aches, joint pain, burning sensation in muscles, pain in feet.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: RED ITCHY RASH ABOVE INJECTION SITE APPROXIAMATELY 2 INCHES WIDE--OBLONG SHAPE.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Left arm injection site red and warm to touch. Redness and warmth extends 6 inches below the site and is 4 inches wide. No tenderness or swelling.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Induration
Clinical narrative: LARGE INDURATION ON OPPOSITE ARM OF VACCINATION SITE.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Vaccine received was Fluzone High dose-Thimerosal free; preservative free: Prolonged pain in the arm for 5 weeks and still counting.  Tried arm stimulation and light exercises first with ice, later with heat and no relief to present time. Husband has same problem (and also other people we know). Have also been to chiropractor with no success. Gave us exercises which we are still doing.  Have talked to other nurses and they have told me they have had some calls with same problem.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Neuritis, Pain, Pain in extremity
Clinical narrative: Sharp burning pain radiating from the right deltoid to the 2nd/3rd digit fingertips, diagnosed with C7 neuritis and started on gabapentin for pain.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left shoulder with 12x9cm erythematous area that is warm and slightly swollen.  No fluctuance or abscess present.  No streaking up arms.
Age: 4.0
Sex: M
Vaccine: DTPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness and heat at the injection site on right deltoid.  Mother applied ice and gave pain reliever.
Age: 29.0
Sex: F
Vaccine: MNQ
Symptoms: Abnormal sensation in eye, Balance disorder, Coordination abnormal, Disorientation, Dizziness
Clinical narrative: Slight redness at injection site very small with slight elevation - "size of pimple"; experienced pressure in head, behind eyes below, and pressure in her ears; went home and experienced mild dizziness when laid down, arm now sore; today now sore at injection site, increase pressure in head and below eyes; no fever; today became dizzy and disoriented; balance and coordination issues.
Age: 29.0
Sex: F
Vaccine: MNQ
Symptoms: Ear discomfort, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Slight redness at injection site very small with slight elevation - "size of pimple"; experienced pressure in head, behind eyes below, and pressure in her ears; went home and experienced mild dizziness when laid down, arm now sore; today now sore at injection site, increase pressure in head and below eyes; no fever; today became dizzy and disoriented; balance and coordination issues.
Age: 29.0
Sex: F
Vaccine: MNQ
Symptoms: Pain in extremity
Clinical narrative: Slight redness at injection site very small with slight elevation - "size of pimple"; experienced pressure in head, behind eyes below, and pressure in her ears; went home and experienced mild dizziness when laid down, arm now sore; today now sore at injection site, increase pressure in head and below eyes; no fever; today became dizzy and disoriented; balance and coordination issues.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest discomfort, Haemorrhage, Nausea, Rash, Secretion discharge
Clinical narrative: Rash from center of chest radiating to left axilla area. Pt states rash oozing and bleeding in axilla area. Chest tightness and nausea. MD prescribed Medrol dosepak, Valtrex, and hydrocodone/APAP and Zyrtec.
Age: 1.26
Sex: F
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: Muscle twitching
Clinical narrative: Involuntary twitching of upper and lower extremities.
Age: 87.0
Sex: M
Vaccine: TD
Symptoms: Arthralgia, Erythema, Local swelling, Musculoskeletal stiffness, Pain
Clinical narrative: Right hand pain/index finger swollen and very stiff/painful in joints in right hand/hurt to move fingers.  Migrating redness on right hand. Middle finger to hand.
Age: 87.0
Sex: M
Vaccine: TD
Symptoms: Pain in extremity
Clinical narrative: Right hand pain/index finger swollen and very stiff/painful in joints in right hand/hurt to move fingers.  Migrating redness on right hand. Middle finger to hand.
Age: 1.26
Sex: F
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: Blood culture negative, Febrile convulsion, Intensive care, White blood cell count increased
Clinical narrative: 2 episodes febrile seizure, brought by EMS to local ER, received Ativan with 2nd seizure, transferred to second hospital PICU for observation and work-up.
Age: 0.55
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Diarrhoea
Clinical narrative: Diarrhea.
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Rash pruritic
Clinical narrative: Itchy rash; some dizziness.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Cystitis, Pyrexia
Clinical narrative: Fever.
Age: 40.0
Sex: M
Vaccine: HEPAB, MNQ, PPV, TDAP
Symptoms: Hyperhidrosis, Loss of consciousness, Somnolence, Syncope
Clinical narrative: Patient fainted upon administration of Tdap. He had already received a meningitis injection. He was passed out approximately 4-5 minutes. He was alert but groggy about 5 more minutes. He had a sweaty forehead but no fever nor clammy skin. Alert > 5 minutes.
Sex: F
Vaccine: VARZOS
Symptoms: Nodule
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date and dose unspecified), subcutaneously. No concomitant therapy was reported. On an unknown date, the patient developed a knot in her arm. No rash or papule was noted. The patient sought medical attention (seen by another pharmacist). It was unspecified if any treatment was given or if any lab tests were performed. The outcome of knot in her arm was unknown. The relatedness for knot in her arm was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from another health professional refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. It was reported that on 03-SEP-2013, GARDASIL went out of range as it was exposed to 31.2 F for 6 hours. On 24-SEP-2013, the patient was administered with this improperly stored GARDASIL (route of administration unknown) for an unknown location. Lot number was reported as H021861 with an expiration date of 09-OCT-2015. No adverse effects were reported. No further information was provided. This is one of 16 reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from another health professional refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. It was reported that on 03-SEP-2013, GARDASIL went out of range as it was exposed to 31.2 F for 6 hours. On 17-SEP-2013, the patient was administered with this improperly stored GARDASIL (route of administration unknown) for an unknown indication. Lot number was reported as H021861 with an expiration date of 09-OCT-2015. No adverse effects were reported. No further information was provided. This is one of 16 reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from another health professional refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. It was reported that on 03-SEP-2013, GARDASIL went out of range as it was exposed to 31.2 F for 6 hours. On 18-SEP-2013, the patient was administered with this improperly stored GARDASIL (route of administration unknown). Lot number was reported as H021861 with an expiration date of 09-OCT-2015. No adverse effects were reported. No further information was provided. This is one of 16 reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age. On 28-OCT-2013, the patient was vaccinated with a dose of RECOMBIVAX HB, (lot number J005891, expiry date 20-SEP-2015) that was exposed to minus 4.5 degree celsius for 90 minutes which was found to be unsupported excursion by in house stability date. No adverse symptoms were reported. Additional information is not expected.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Received Flu shot on 10/29, on 10/30 pt noticed mild redness, swelling and itching over the site. 5cm mild erythematous area consistent with urticaria on left deltoid.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Mental impairment, Speech disorder, Visual impairment
Clinical narrative: About 45 minutes started seeing clear shapes, the eventually get bigger, that lasted about 30 min or so, then I had trouble getting my words out, I couldn't think straight, I was calling a little boy a she or her main thing I couldn't get my brain to work with my mouth. This lasted for about an hour.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Myalgia
Clinical narrative: The evening of the vaccine, the patient experienced severe muscle pain and an inability to move left arm. This continued until the next morning when she notified the provider.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth, itch at site.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: The patient that received the flu shot developed Guillain-Barre syndrome.
Age: 54.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Reports later pm 10-17-13 arm started hurting and by next am was having problems raising (L) arm - after several days she called doctor and was advised to use ice and ibuprofen. Has been doing this. Is able to lift arm - higher now then when 1st started. Is to call doctor but if it doesn't resolve.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema multiforme, Injection site pain, Injection site pruritus, Injection site reaction, Injection site urticaria
Clinical narrative: 15 cm size area extending from injection site to elbow. Symptoms: Erythema Multiform, Urticaria Pruritus and tenderness. Treatment: Doxycycline 100 mg BID.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from another health professional refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. It was reported that on 03-SEP-2013, GARDASIL went out of range as it was exposed to 31.2 F for 6 hours. On 20-SEP-2013, the patient was administered with this improperly stored GARDASIL (route of administration unknown) for an unknown indication. Lot number was reported as H021861 with an expiration date of 09-OCT-2015. No adverse effects were reported. No further information was provided. This is one of 16 reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: FLU3
Symptoms: Amylase increased, Computerised tomogram abnormal, Gastroenteritis, Lipase increased, Nausea
Clinical narrative: Initial report received from a healthcare professional on 15 October 2013. A female patient had received an intramuscular dose of Flu vaccine from Sanofi Pasteur manufacturer (Batch number, route, dose number and anatomical site of vaccination was not reported) on an unspecified date. The patient is allergic to Penicillin and concomitant medications were not reported. On an unspecified date after vaccination, the patient presented to the hospital ER (Emergency room) with complaints of nausea, vomiting and gastroenteritis. On 14 October 2013, the patient was admitted to the hospital and had elevated lipase, amylase and had a CT scan with diagnosis of low grade pancreatitis. The corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome of the event was reported as unknown. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Pancreatitis, Vomiting
Clinical narrative: Initial report received from a healthcare professional on 15 October 2013. A female patient had received an intramuscular dose of Flu vaccine from Sanofi Pasteur manufacturer (Batch number, route, dose number and anatomical site of vaccination was not reported) on an unspecified date. The patient is allergic to Penicillin and concomitant medications were not reported. On an unspecified date after vaccination, the patient presented to the hospital ER (Emergency room) with complaints of nausea, vomiting and gastroenteritis. On 14 October 2013, the patient was admitted to the hospital and had elevated lipase, amylase and had a CT scan with diagnosis of low grade pancreatitis. The corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome of the event was reported as unknown. List of documents held by sender: none.