chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS, FLUX, VARZOS, FLU3, VARZOS
Symptoms: Blood test normal, Drug administered at inappropriate site, Feeling hot, Headache, Injection site erythema
Clinical narrative: This consumer report (initial receipt 10-Sep-2014) concerns a 60 year old female patient who had a medical history of hypertension, fibromyalgia and shingles (twice). The patient had experienced an adverse reaction/allergy to sulfa drugs, nortriptyline, morphine and was allergic to tape. Concomitant medications included duloxetine, pregabalin, ampicillin, 'vesylate', benazepril, oxycodone/paracetamol, simvastatin, pantoprazole, alprazolam. On the 16-Aug-2014, the patient received the influenza virus vaccine (manufacturer and batch number not reported) and concomitantly received the ZOSTAVAX vaccine 1 injection via the subcutaneous route. Both vaccines were given in the same arm. The patient felt like the vaccinations were given in a strange location, near her underarm on the underside of her arm. On the 16-Aug-2014, the patient developed a headache, got really hot, red and swollen at the injection site. By the next night (17-Aug-2014), the injection site had swollen to the size of an egg and the swelling migrated down her arm. The patient went to an Emergency Room (ER) where she was treated and sent home. Her symptoms started to clear up. On the Saturday morning (date unspecified), she woke up feeling paralysed on the right side of her face. She went back to the hospital and was hospitalised overnight. She was diagnosed with Bell's Palsy. Treatment included valacyclovir tablets. Lab diagnostic showed normal bloodwork. Outcome was unknown.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS, FLUX, VARZOS, FLU3, VARZOS
Symptoms: Injection site swelling, VIIth nerve paralysis
Clinical narrative: This consumer report (initial receipt 10-Sep-2014) concerns a 60 year old female patient who had a medical history of hypertension, fibromyalgia and shingles (twice). The patient had experienced an adverse reaction/allergy to sulfa drugs, nortriptyline, morphine and was allergic to tape. Concomitant medications included duloxetine, pregabalin, ampicillin, 'vesylate', benazepril, oxycodone/paracetamol, simvastatin, pantoprazole, alprazolam. On the 16-Aug-2014, the patient received the influenza virus vaccine (manufacturer and batch number not reported) and concomitantly received the ZOSTAVAX vaccine 1 injection via the subcutaneous route. Both vaccines were given in the same arm. The patient felt like the vaccinations were given in a strange location, near her underarm on the underside of her arm. On the 16-Aug-2014, the patient developed a headache, got really hot, red and swollen at the injection site. By the next night (17-Aug-2014), the injection site had swollen to the size of an egg and the swelling migrated down her arm. The patient went to an Emergency Room (ER) where she was treated and sent home. Her symptoms started to clear up. On the Saturday morning (date unspecified), she woke up feeling paralysed on the right side of her face. She went back to the hospital and was hospitalised overnight. She was diagnosed with Bell's Palsy. Treatment included valacyclovir tablets. Lab diagnostic showed normal bloodwork. Outcome was unknown.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS, FLUX, VARZOS, FLU3, VARZOS
Symptoms: Blister, Cellulitis, Erythema, Swelling
Clinical narrative: This consumer report (initial receipt 10-Sep-2014) concerns a 60 year old female patient who had a medical history of hypertension, fibromyalgia and shingles (twice). The patient had experienced an adverse reaction/allergy to sulfa drugs, nortriptyline, morphine and was allergic to tape. Concomitant medications included duloxetine, pregabalin, ampicillin, 'vesylate', benazepril, oxycodone/paracetamol, simvastatin, pantoprazole, alprazolam. On the 16-Aug-2014, the patient received the influenza virus vaccine (manufacturer and batch number not reported) and concomitantly received the ZOSTAVAX vaccine 1 injection via the subcutaneous route. Both vaccines were given in the same arm. The patient felt like the vaccinations were given in a strange location, near her underarm on the underside of her arm. On the 16-Aug-2014, the patient developed a headache, got really hot, red and swollen at the injection site. By the next night (17-Aug-2014), the injection site had swollen to the size of an egg and the swelling migrated down her arm. The patient went to an Emergency Room (ER) where she was treated and sent home. Her symptoms started to clear up. On the Saturday morning (date unspecified), she woke up feeling paralysed on the right side of her face. She went back to the hospital and was hospitalised overnight. She was diagnosed with Bell's Palsy. Treatment included valacyclovir tablets. Lab diagnostic showed normal bloodwork. Outcome was unknown.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Pyrexia
Clinical narrative: Fever 101.5. Burning in arm. Throbbing in arm. Tight chest. (R) armpit swollen and painful. Blurred vision/dizzy.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Axillary pain, Burning sensation, Chest discomfort, Dizziness, Oedema peripheral
Clinical narrative: Fever 101.5. Burning in arm. Throbbing in arm. Tight chest. (R) armpit swollen and painful. Blurred vision/dizzy.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pain, Pain in extremity, Pyrexia, Vision blurred
Clinical narrative: Fever 101.5. Burning in arm. Throbbing in arm. Tight chest. (R) armpit swollen and painful. Blurred vision/dizzy.
Age: 66.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Chills, Dizziness, Eye pain, Oropharyngeal pain, Pain
Clinical narrative: Chills, fever, sore throat, swollen tongue and tremors.
Age: 66.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pyrexia, Tremor
Clinical narrative: Chills, fever, sore throat, swollen tongue and tremors.
Age: 66.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Chills, Oropharyngeal pain, Pyrexia, Swollen tongue, Tremor
Clinical narrative: Chills, fever, sore throat, swollen tongue and tremors.
Age: 4.0
Sex: F
Vaccine: DTAP, HIBV, MEN
Symptoms: Crying, Discomfort, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Entire upper arm is largely swollen, very red, and hot to the touch. She is unable to sleep, and is wakeful, crying and in pain. Later in the morning, I observe the arm is very swollen, hot, and red - taking up her entire arm from elbow to shoulder. She seems fine all day, and even goes to school, complaining of only some discomfort.
Age: 4.0
Sex: F
Vaccine: DTAP, HIBV, MEN
Symptoms: Insomnia, Pain
Clinical narrative: Entire upper arm is largely swollen, very red, and hot to the touch. She is unable to sleep, and is wakeful, crying and in pain. Later in the morning, I observe the arm is very swollen, hot, and red - taking up her entire arm from elbow to shoulder. She seems fine all day, and even goes to school, complaining of only some discomfort.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Herpes zoster, Malaise
Clinical narrative: Headache & general unwell feeling began 9/11/2015. Initial signs of shingles rash appeared on 9/15/2014.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Herpes zoster, Nasopharyngitis, Rash
Clinical narrative: Headache & general unwell feeling began 9/11/2015. Initial signs of shingles rash appeared on 9/15/2014.
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Paralysis
Clinical narrative: This spontaneous report as received from a pharmacist via company representative who received information from consumer and refers to a patient (consumer's friend) of unknown age and gender. The patient's pertinent medical history was not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). Concomitant therapies included unspecified influenza virus vaccine. On an unknown date, the patient experienced paralysis after receiving ZOSTAVAX and an unspecified influenza virus vaccine. The outcome of the paralysis was unknown. The relatedness between the paralysis and the vaccination with ZOSTAVAX was unknown. Upon internal review the paralysis was considered to be medically significant. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Local swelling, Tenderness
Clinical narrative: Noted arm to be tender and swollen with about 10 cm in diameter focused area.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: Pain at site of injection; upper left arm.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Vertigo
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a 57 year old female patient. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (1 shot, dose unspecified, lot# and expiration date were not reported) for prevention of shingles. On an unknown date, 2 days after vaccination the patient's left side of body had lots of achiness, her arm hurt and she had a slight vertigo. The patient sought medical attention. No treatment was given for the events. The patient recovered from the events (date unspecified). Relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 16-SEP-2014 the patient was vaccinated with expired dose of PNEUMOVAX 23 (0.5 ml, intramuscular, lot# J002646, expiry date: 11-MAR-2014). Pertinent medical history and concomitant medications were unspecified by reporter. No adverse effects were reported. The outcome of the events was unknown. No further information was provided. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Abnormal dreams, Headache
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 68 year old male patient. Patient's concurrent condition included end stage renal disease. The patient's medical history included heart transplant and drug reactions/allergies were none. On 16-SEP-2014 the patient was vaccinated with PNEUMOVAX 23, 0.5 ml, (lot number: K001504 with expiry date of 28-MAR-2015) intramuscularly as a part of protocol. Concomitant medications were unknown. On 16-SEP-2014, the patient also began hemodialysis treatment. On 16-SEP-2014, the patient had a headache and experienced crazy dreams. The patient sought medical attention by calling healthcare professional on 19-SEP-2014. The outcome of the events headache and crazy dreams was reported as not recovered/not resolved. The causality of the events with PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Musculoskeletal stiffness
Clinical narrative: ARM STILL STIFF, VERY TIRED.
Age: 80.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 80 year old patient of unknown gender. On an unknown date the patient received a dose of improperly stored ZOSTAVAX (lot# not reported, dose 0.65 ml, subcutaneous), exposed to 32.3F for 70 hours. Concomitant medications were not provided. No adverse effects were reported. This is one of two reports received from the same reporter (other MARRS# 1409USA009261). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 17-SEP-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23, injection, 0.5 ml, intramuscularly, (lot # J009827, expired date: 10-AUG-2014). Concomitant therapy was not reported. No adverse effects reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a medical assistant via a company representative and refers to a currently 8 year 9 month old patient of unspecified gender. Vaccination history included: On 30-DEC-2005 (dose 1), 05-MAR-2006 (dose 2), 09-MAY-2006 (dose 3)0, 30-OCT-2006 (dose 4), 29-MAR-2010 (dose 5): DTP/DTaP/DT (manufacturer unknown). On 30-DEC-2005 (dose 1), 05-MAR-2006 (dose 2), 09-MAY-2006 (dose 3), 09-MAY-2007 (dose 4); (unspecified carrier) HIB (manufacturer unknown). On 30-DEC-2005 (dose 1), 05-MAR-2006 (dose 2), 09-MAY-2006 (dose 3), 29-MAR-2010 (dose 4) poliovirus vaccine (unspecified) POLIO (manufacturer unknown). On 30-OCT-2006 (dose 1) and 29-MAR-2010 (dose 2) MMR (manufacturer unknown). On 29-OCT-2005 (dose 1), 30-DEC-2005 (dose 2), 06-MAR-2006 (dose 3) and 09-MAY-2006 (dose 4) hepatitis B virus vaccine (unspecified) HEP-B (manufacturer unknown)0. On 30-DEC-2005 (dose 1), 05-MAR-2006 (dose 2), 09-MAY-2006 (dose 3), 04-MAY-2007 (dose 4) and 16-SEP-2010 (dose 5) (unspecified) PNEUMO PCV (manufacturer unknown). On 30-OCT-2006 (dose 1) and 04-MAY-2007 (dose 2) (unspecified) HEP-A (manufacturer unknown). On 08-NOV-2010 (unspecified) (reported as FLU). On 30-OCT-2006 (dose 1) and on 29-MAR-2010 (dose 2) the patient was vaccinated with (Oka/Merck) VARIVAX (reported as CHICKENPOX) (dose, units, route of administration, anatomical location, lot number were not reported). On an unknown date the patient experienced chickenpox/chickenpox describes as spots and fever. The outcome of event was reported as not recovered/not resolved. The relatedness between event and (Oka/Merck) VARIVAX was not reported. This is one of several reports from the same reporter. Additional information is not expected because address was correctly entered but the correspondence was returned.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Pt called pharmacy on 9/19 stating that injection site was swollen, felt warm and was firm. Symptoms started that evening and had progressed since.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Diarrhoea, Nausea, Pain in extremity
Clinical narrative: Shivering, nausea, vomiting, diarrhea and pain in hips and thigh regions. Duration into 5:00 AM when able to fall asleep. Tried Aspirin and Advil with no relief.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Shivering, nausea, vomiting, diarrhea and pain in hips and thigh regions. Duration into 5:00 AM when able to fall asleep. Tried Aspirin and Advil with no relief.
Age: 0.18
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontanoeus report as received from a nurse refers to a 9 week old female patient. According to the patient's mother, the patient's records reflected a GARDASIL vaccine (dose, route, lot # and expired date were not reported) administered to the patient on 11-AUG-2011. Concomitant therapy was not reported. The nurse stated that GARDASIL might have been administered to a 2 month old patient. No adverse effect reported. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Eye pain, Nuclear magnetic resonance imaging brain abnormal, Optic neuritis, Visual acuity reduced
Clinical narrative: Patient presented to Ophthalmologist on September 4, 2014 for emergency appointment from atypical symptoms that had progressed since first noticed on Saturday, August 30 and had pain in left eye, little to no acuity upon exam. Ophthalmologist diagnosed Optic Neuritis and sent patient for a STAT MRI of Brain and Contrast of Orbits. Patient PCP was consulted and PCP sent patient directly to ER for immediate treatment and before MRI to be completed in which IV Steroids were administered (1000 mg, 1x per day 9/5, 9/6, 9/7) and admittance to Hospital for duration of treatment. MRI of Brain and with contrast of Orbits was completed on Friday September 5, 2014 and confirmed diagnosis of Optic Neuritis. Patient remained in hospital through 9/7 and was released on oral steroids, gradual diminishing dosages through 9/18.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Oedema mouth, Pharyngeal oedema
Clinical narrative: Developed, cough swelling of throat, mouth, SOB. Treated in Emergency Room - SOLUCORTEF, BENADRYL, PEPCID.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Approximately on 16-SEP-2014 (reported as "probably yesterday") the patient was vaccinated intramuscularly with an expired dose of PNEUMOVAX 23 (0.5 ml, lot # H022172, expiration date 16-AUG-2014). No adverse effect was reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse and refers to a patient of unknown age and gender. On 23-JUN-2014 the patient was intended to receive an unspecified meningococcal vaccine, was inadvertently administered LIQUID PEDVAXHIB 0.5 ml, intramuscular, lot # H010726, expiration date: 18-OCT-2014) due to nursing error. No adverse effects reported. Additional information is not expected because the reporter refused to contact the physician.
Age: 1.0
Sex: U
Vaccine: RV5
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 month old patient. On 08-SEP-2014, the patient was vaccinated a 4th dose of ROTATEQ (dose 2ml, lot# and expiration date were unkonwn) oral. This patient had previously completed the ROTATEQ series, with doses given on: 26-NOV-2014, 23-JAN-2014, 14-MAR-2014. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown gender and age. On 12-SEP-2014, the patient was vaccinated with an expired dose of ROTATEQ 2ml dose, oral, lot number J000988, expiration date: 11-SEP-2014 (dose number not reported). It was reported that the potency was supported. No adverse effect to patient. The patient did not seek medical attention. No product quality complaint (PQC) involved. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a physician refers to a 65 year old male patient without drug reactions/allergies with hypertension and hyperlipidemia. On 25-AUG-2014, the patient was vaccinated with ZOSTAVAX single dose (lot # J013135, exp date: 17-JAN-2015) subcutaneously. Concomitant therapies included CRESTOR. On an unspecified date in 2014, the patient experienced shingles-like rash. The distribution of the rash was not provided. The patient sought medical attention, he called to the office. No treatment was given for the adverse event. No labs diagnostic tests were performed. The outcome of he has a shingles-like rash was reported as not recovered/not resolved. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Local swelling, Throat tightness
Clinical narrative: Throat tightness. Severe arm swelling.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 3 year old (child) male patient. On 17-SEP-2014 (reported as "today") the patient was vaccinated intramuscularly in the left upper thigh with an expired dose of PNEUMOVAX 23 (0.5 ml, lot # 670875/0631AA, expiration date 21-JAN-2013). No adverse effects were reported. No PQC (product quality complaint) was involved. Additional information is not expected, because there is no consent for further contact.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant and refers to a 2 patients of unknown age and gender. On an unknown date those patients were vaccinated with PNEUMOVAX 23 (dose, units, route of administration, anatomical location, lot number were not reported) after being stored improperly. No adverse effects reported. Additional information has been requested.
Age: 36.0
Sex: M
Vaccine: FLUX
Symptoms: Vertigo
Clinical narrative: Vertigo, first noticed when I bent down to get a pan to cook breakfast. Vertigo has continued for 2 days whenever I move my head quickly.
Age: 12.0
Sex: F
Vaccine: FLUX
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Guillain-Barre syndrome
Clinical narrative: A 12 year-old female patient (date of birth not reported) had received on an unspecified date a "common flu shot" (manufacturer, route and site of administration not reported) and an unspecified amount of time later developed Guillain-Barre syndrome. According to the parent, "it became chronic" and the patient now deals with CIDP. The patient lives in a college dorm. No further information was available at the time of the report. Outcome was not reported. Documents held by sender: none.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Vaccination site swelling
Clinical narrative: Initial report received from a health care professional on 15 September 2014. An 80-year-old female patient, with no reported medical history or concomitant medications, received an intramuscular left deltoid injection of FLUZONE HIGH DOSE (lot number U5042AA) on 12 September 2014. That same evening, she presented to the emergency department with swelling and redness around the vaccination site. She was diagnosed with cellulitis and treated with Cephalexin. As of 15 September 2014, the area was "much better" and only slightly red. No information regarding laboratory testing was reported, and the patient had not yet recovered at the time of the report. Documents held by sender: None.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Pericardial disease, Pericarditis
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. A 26 year-old male subject with a past medical history of chest pain, chest pressure, shortness of breath, asthma and psychiatric illness was diagnosed with "other and unspecified acute pericarditis" on 30 April 2014, 22 days after the subject had received the following vaccine on 08April 2014: an injection of ACAM2000 (lot number and site of administration not reported. On 07 May 2014, "acute pericarditis unspecified" was diagnosed; and on 08 May 2014, "Unspecified disease of pericardium" was diagnosed. Troponin I was not performed. On 30 April 2014 an ECG was abnormal and on 08 April 2014 an echocardiogram was normal. Lumbar puncture (spinal tap) and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.                    Adjudication Data Entry       Select the radio button next to any fields that need editing and enter data.   Box 7 Describe Adverse Event  (and treatment if any)
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: This spontaneous report as received from a health professional via agency (manufacturer control number 58348) refers to a elderly male patient of unknown age (over 65 years old). The patient did not have any known allergies. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route not reported, lot # K005797, expiration date 21-MAR-2015, or lot# reported as K007773). Concomitant therapies were not provided. On 18-AUG-2014 the patient experienced redness, fever in the area upper arm and itching in the area. After a couple of days it went away on its own and the patient was okay. The healthcare worker stated the office already disposed one of the lot numbers that was used that was causing the issue lot # K005797. This is one of four reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Abnormal behaviour, Antisocial behaviour, Paranoia, Social avoidant behaviour
Clinical narrative: This spontaneous report as received from a consumer refers to his son - a currently 16 years old male patient with no learning disabilities and no drug allergies. On an unknown date in 2010 or 2011 (reported as '3-4 years ago'), the patient was vaccinated with the first dose of GARDASIL (dose, batch/lot #, expiration date not reported). No concomitant medication was reported. On an unknown date, reported as within days after vaccination, the patient experienced a change in behaviour and became withdrawn, paranoid and antisocial. On an unknown date, reported as 1 year after the first dose, the patient was vaccinated with the second dose of GARDASIL (dose, batch/lot#, expiration date not reported), for prophylaxis and the symptoms of change of behaviour, withdrawn, paranoid and antisocial immediately became "ten times worse". The patient sought medical attention by visiting the office but no diagnostic studies were performed and no treatment was prescribed. The outcome of adverse events the patient experienced after the first dose of GARDASIL was unknown. The patient's present status was reported as not recovered. The relatedness between adverse events and therapy with GARDASIL was not reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Asthenia, Dizziness, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Injection site: Extensive swelling, hard lump, redness, warmth and very painful. Side effects: Unrelenting migraine headache, weakness, dizziness, nausea, irritability (because not feeling well and/or not able to sleep?)...
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Insomnia, Irritability
Clinical narrative: Injection site: Extensive swelling, hard lump, redness, warmth and very painful. Side effects: Unrelenting migraine headache, weakness, dizziness, nausea, irritability (because not feeling well and/or not able to sleep?)...
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Malaise, Migraine, Nausea
Clinical narrative: Injection site: Extensive swelling, hard lump, redness, warmth and very painful. Side effects: Unrelenting migraine headache, weakness, dizziness, nausea, irritability (because not feeling well and/or not able to sleep?)...
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Abdominal discomfort, Dizziness, Fatigue, Injection site pain, Injection site swelling
Clinical narrative: Injection site: Extensive swelling, hard lump, redness, warmth and very painful. Side effects: Unrelenting migraine headache, weakness, dizziness, nausea, irritability (because not feeling well and/or not able to sleep?)...
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Asthenia, Dizziness, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Pain and swelling at injection site. Dizzy, Fatigue, Sick to stomach - Symptoms lasted a week.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Insomnia, Irritability
Clinical narrative: Pain and swelling at injection site. Dizzy, Fatigue, Sick to stomach - Symptoms lasted a week.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Malaise, Migraine, Nausea
Clinical narrative: Pain and swelling at injection site. Dizzy, Fatigue, Sick to stomach - Symptoms lasted a week.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Abdominal discomfort, Dizziness, Fatigue, Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling at injection site. Dizzy, Fatigue, Sick to stomach - Symptoms lasted a week.
Sex: U
Vaccine: HPV4
Symptoms: Abnormal behaviour
Clinical narrative: This spontaneous reported as received from a consumer refers to 4 children patients (gender and exact age not provided). The consumer stated, that heard about four children, who on an unknown date, were vaccinated with GARDASIL (dose, batch/lot #, expiration date not reported), and experienced behavior changes. Action taken and outcome of adverse event was unknown. The relatedness between adverse event and therapy with GARDASIL was not reported. This is one of several received from the same reporter. 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 pharmacist refers to a currently 74 year old patient of unknown gender. On an unknown date the patient received a dose of improperly stored ZOSTAVAX (lot# not reported, dose 0.65 ml, subcutaneous), exposed to 32.3F for 70 hours. Concomitant medications were not provided. No adverse effects were reported. This is one of two repors received from the same reporter (other MARRS# 1409USA009346). Additional information has been requested.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Injection site swelling, Local swelling, Swelling face, Urticaria
Clinical narrative: Hives and swelling on the cheek and arm as well on the thigh of the injection site.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Pain in extremity, Rash erythematous, Skin warm
Clinical narrative: Rash appears as small, red bumps that are raised. Slightly warm to touch. Pt c/o leg pain with ambulating.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Eye movement disorder, Tremor
Clinical narrative: She was walking out of clinic. Felt faint.  Got dizzy, eyes rolled, & started shaking.  Sat down.  Started to feel better.
Age: 67.0
Sex: F
Vaccine: DTAP, FLU3, PPV
Symptoms: Arthralgia, Asthenia, Chest X-ray, Cough, Erythema
Clinical narrative: Immediately extreme pain at site. The injected medicine pooled at two sites under the skin and red dots and swelling at site for several days. Next day tiredness swept over my entire body like a wave and stayed and then the next day weakness and more tiredness, then full blown sickness headache, pain joint, stuff nose, cough severe and I mean extreme Exhaustion!! Went back to the Doctor's office four times.
Age: 67.0
Sex: F
Vaccine: DTAP, FLU3, PPV
Symptoms: Fatigue, Headache, Immediate post-injection reaction, Injection site pain, Injection site swelling
Clinical narrative: Immediately extreme pain at site. The injected medicine pooled at two sites under the skin and red dots and swelling at site for several days. Next day tiredness swept over my entire body like a wave and stayed and then the next day weakness and more tiredness, then full blown sickness headache, pain joint, stuff nose, cough severe and I mean extreme Exhaustion!! Went back to the Doctor's office four times.
Age: 67.0
Sex: F
Vaccine: DTAP, FLU3, PPV
Symptoms: Malaise, Nasal congestion, Streptococcus test negative
Clinical narrative: Immediately extreme pain at site. The injected medicine pooled at two sites under the skin and red dots and swelling at site for several days. Next day tiredness swept over my entire body like a wave and stayed and then the next day weakness and more tiredness, then full blown sickness headache, pain joint, stuff nose, cough severe and I mean extreme Exhaustion!! Went back to the Doctor's office four times.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Dysstasia, Gait disturbance, Injection site erythema, Joint swelling
Clinical narrative: Started with sore arm afternoon of injection. Redness developed around injection site, approx. 1cm in diameter. Following morning, 9/17/14, approx 6:00am, knees and elbows, other major joints started feeling sore, swollen, achy. Took 800mg ibuprofen at 8:00am - after 30 - 40 minutes pain level was still rising, to the point where it was extremely painful to stand and walk. Went home from work at 9:00am, rested, elevated legs, iced knees. Took Naproxen at 3:00pm, same day. No significant pain relief. Couldn't stand for any significant time period without extreme pain. Following day, 9/18/14, knees felt a little better in the morning, elbows felt a little better. Took Naproxen at 5:30am. Unable to determine whether it helped or not. Swelling, aching joints gradually felt better throughout day. This morning, 9/19/14, almost feel 100% normal - about 90% normal. Anticipating feeling gradually better throughout today, 9/19/14.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: Started with sore arm afternoon of injection. Redness developed around injection site, approx. 1cm in diameter. Following morning, 9/17/14, approx 6:00am, knees and elbows, other major joints started feeling sore, swollen, achy. Took 800mg ibuprofen at 8:00am - after 30 - 40 minutes pain level was still rising, to the point where it was extremely painful to stand and walk. Went home from work at 9:00am, rested, elevated legs, iced knees. Took Naproxen at 3:00pm, same day. No significant pain relief. Couldn't stand for any significant time period without extreme pain. Following day, 9/18/14, knees felt a little better in the morning, elbows felt a little better. Took Naproxen at 5:30am. Unable to determine whether it helped or not. Swelling, aching joints gradually felt better throughout day. This morning, 9/19/14, almost feel 100% normal - about 90% normal. Anticipating feeling gradually better throughout today, 9/19/14.
Age: 26.0
Sex: M
Vaccine: HPV4
Symptoms: Disturbance in attention, Fatigue, Feeling hot, Hyperhidrosis, Joint stiffness
Clinical narrative: Client received HPV vaccine dose #1 today. At approximately 8:50 am, client was given injection. Following injection, client was alert and responsive asking questions about other immunizations. Approximately 2 minutes following injection client stated he was not feeling well, leaned against the wall, skin turned a greenish hue, and client lost consciousness for approximately 30 seconds, accompanied by seizure-like movements that lasted approximately 15 seconds. Client was not responsive, his eyes were open but not focused, his body became rigid and his arms tightened up. Client was seated during the episode. Following the episode the client became responsive, but asked "where am I", after RN told him he had just received his shot he again became fully aware of his surroundings. Client's skin color remained a greenish hue and he stated feeling very tired, sweaty, nauseous and hot. Client was given a juice box and laid down on the floor. During the episode, RN provided supportive care ensuring client safety. Greenish hue to skin color dissipated within 3 minutes and client remained pale for another 2 minutes. EMS was not called as client was fully recovered from the episode within 5 minutes. Client remained seated with RN monitoring for 15 minutes, and then moved to the waiting room, where he remained for an additional 15 minutes of RN monitoring. Client was given a 2nd juice box while waiting, and did not experience any additional side effects.
Age: 26.0
Sex: M
Vaccine: HPV4
Symptoms: Loss of consciousness, Malaise, Muscle rigidity, Nausea, Pallor
Clinical narrative: Client received HPV vaccine dose #1 today. At approximately 8:50 am, client was given injection. Following injection, client was alert and responsive asking questions about other immunizations. Approximately 2 minutes following injection client stated he was not feeling well, leaned against the wall, skin turned a greenish hue, and client lost consciousness for approximately 30 seconds, accompanied by seizure-like movements that lasted approximately 15 seconds. Client was not responsive, his eyes were open but not focused, his body became rigid and his arms tightened up. Client was seated during the episode. Following the episode the client became responsive, but asked "where am I", after RN told him he had just received his shot he again became fully aware of his surroundings. Client's skin color remained a greenish hue and he stated feeling very tired, sweaty, nauseous and hot. Client was given a juice box and laid down on the floor. During the episode, RN provided supportive care ensuring client safety. Greenish hue to skin color dissipated within 3 minutes and client remained pale for another 2 minutes. EMS was not called as client was fully recovered from the episode within 5 minutes. Client remained seated with RN monitoring for 15 minutes, and then moved to the waiting room, where he remained for an additional 15 minutes of RN monitoring. Client was given a 2nd juice box while waiting, and did not experience any additional side effects.
Age: 26.0
Sex: M
Vaccine: HPV4
Symptoms: Seizure like phenomena, Skin discolouration, Unresponsive to stimuli
Clinical narrative: Client received HPV vaccine dose #1 today. At approximately 8:50 am, client was given injection. Following injection, client was alert and responsive asking questions about other immunizations. Approximately 2 minutes following injection client stated he was not feeling well, leaned against the wall, skin turned a greenish hue, and client lost consciousness for approximately 30 seconds, accompanied by seizure-like movements that lasted approximately 15 seconds. Client was not responsive, his eyes were open but not focused, his body became rigid and his arms tightened up. Client was seated during the episode. Following the episode the client became responsive, but asked "where am I", after RN told him he had just received his shot he again became fully aware of his surroundings. Client's skin color remained a greenish hue and he stated feeling very tired, sweaty, nauseous and hot. Client was given a juice box and laid down on the floor. During the episode, RN provided supportive care ensuring client safety. Greenish hue to skin color dissipated within 3 minutes and client remained pale for another 2 minutes. EMS was not called as client was fully recovered from the episode within 5 minutes. Client remained seated with RN monitoring for 15 minutes, and then moved to the waiting room, where he remained for an additional 15 minutes of RN monitoring. Client was given a 2nd juice box while waiting, and did not experience any additional side effects.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Decreased appetite, Dizziness, Fatigue, Pain, Paranasal sinus hypersecretion
Clinical narrative: Patient states that when he woke up on Wednesday 9/17/14 he had generalized body aches, sinus drainage, lack of appetite, fatigue, light headedness and a widespread red rash on his bilateral arm and legs.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Rash erythematous, Sinus disorder
Clinical narrative: Patient states that when he woke up on Wednesday 9/17/14 he had generalized body aches, sinus drainage, lack of appetite, fatigue, light headedness and a widespread red rash on his bilateral arm and legs.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Redness, swelling, soreness, warmth.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Extensive swelling below the injection site recommended 1-2 doses of diphenhydramine 25mg.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (certified medical assistant) refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On 12-SEP-2014, the patient was vaccinated with a dose of ROTATEQ (route of administration not reported, defaulted to oral; dose, indication, lot# and expiry date unspecified) and a dose of PEDVAXHIB injection (dose, route of administration, indication, lot# and expiry date unspecified) that were exposed to temperatures outside of the proper storage range. No concomitant medications were reported. No adverse effect was 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 nurse practitioner refers to a patient of unknown age and gender. Medical history was not reported. The nurse practitioner informed that on 09-SEP-2014 the patient was inadvertently vaccinated with ad dose of PNEUMOVAX 23 lot # J004080, expiration date: 22-AUG-2014, intramuscular (dosage was not reported), which expired on 22-AUG-2014. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. It was reported that the patient received dose one of GARDASIL, injection (lot# and expiration date not provided) (dose not reported) in November 2012 and dose two of GARDASIL, injection (lot# and expiration date not provided) (dose not reported) in January 2013 and a dose three GARDASIL, injection (lot# and expiration date provided) (dose not reported) on 08-SEP-2014, all intramuscularly. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: This spontaneous report was received from a physician via sales representative refers to a female patient of unknown age. Medical history was not reported. On an unknown date the patient was vaccinated with GARDASIL (dose, dosage, route and lot number were not reported) for prevention of HPV. Concomitant therapy was not reported. The physician informed that on an unknown date the patient experienced headache after being administered the GARDASIL vaccine. The outcome of the event was unknown. Additional information is not expected because the reporter refused to be contacted.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 61 year old patient. Patient's medical history was unspecified by the reporter. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, frequency, route of administration and anatomical location: unkonwn) (lot # K000995, exp date: 16-MAR-2015). On an unkonwn date, injection site of the female patient was swollen and red (also reported as "more severe reaction than the other patients"). The patient visited her unspecified physician on an unspecified date. The outcome of injection site was swollen and red was reported as recovered on an unknown date. The relatedness between the events and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pruritus, Swollen tongue, Throat irritation, Throat tightness, Urticaria
Clinical narrative: ITCHING, SWELLING AT THE SORE THROAT.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Oropharyngeal pain, Pruritus, Swelling
Clinical narrative: ITCHING, SWELLING AT THE SORE THROAT.
Sex: U
Vaccine: PPV, VARCEL, VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unkonwn number of patients of unkonwn age. On an unkonwn date the patients were vaccinated with ZOSTAVAX, VARIVAX (Merck) and PNEUMOVAX 23 (lot#, expiration date, dose and frequency were unknown). In July 2014 (reported as for the last 2 months) there were multiple excursions occurred with vaccines PNEUMOVAX 23, ZOSTAVAX and VARIVAX (Merck) and most likely they were administered to patients. The reporter did not provide actual excursion information. No adverse event reported. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Headache, Heart rate increased, Malaise
Clinical narrative: Severe chills, fever, rapid heart beat, joint pain, sick to stomach, extreme headache. So sick could not call for help. Symptoms lasted for 12 hours.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Pyrexia
Clinical narrative: Severe chills, fever, rapid heart beat, joint pain, sick to stomach, extreme headache. So sick could not call for help. Symptoms lasted for 12 hours.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Pt called 2 days following vaccine to report arm swollen, reddened & itchy, had tried cold compresses with no relief.  Advised by nurse in our office for pt to contact pt's primary MD to report same.  MD saw patient next day & began antibiotics to treat possible cellulitis.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Patient developed a 6 inch circle on right arm where vaccine administered. Later became warm to touch. Patient was prescribed Cephalexin for possible infection. Otherwise patient unharmed.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling and warmth at site of injection.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to four patients of unknown age and gender. Patient's medical histories were not reported. On an unknown date the patients were vaccinated with ZOSTAVAX (dose, frequency, route of administration and anatomical location: unknown) (lot # K000995, exp date: 16-MAR-2015). On an unknown date, the patient experienced a mild injection site reaction of redness at injection site. The adverse reaction resolved on its own (date unknown). The relatedness between the events and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test abnormal, Viral titre
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. In May 1996 and June 2007 the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (dose, dosage, route and lot number were not reported). Concomitant therapy was not reported. The nurse informed that on an unspecified date (also report was recently) the patients titers were checked because of school requirement and the result was in the equivocal range. The outcome of the event was unknown. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient developed redness and extensive swelling around the injection site. He was treated with ice, acetaminophen, and an oral steroid (methyllprednisolone).
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered refers to an unspecified patient. On 09-SEP-2014 the patient was vaccinated with expired MMR II (dose, frequency, lot no. unknown). The lot had expired on 24-AUG-2014. No concomitant medication was reported. No adverse effects were reported. Product quality complaint was not involved. The outcome of events was unknown. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Her arm was sore after she received the FLUZONE HIGH-DOSE shot. Even after several days, pain continues and she can't move/lift arm.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Injection site pain, Pyrexia
Clinical narrative: Under injected arm is hurting. Weakness, fever.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient called and said that the injection site is swollen big like a fist of hand, redness, itching. I counsel pt to take BENADRYL, Ibu and call MD if symptoms is not improved.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt arm slightly swollen and red from injection site to above elbow.