chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 02-DEC-2013 the patient was vaccinated with RECOMBIVAX HB. Dose, lot and expiry date were unknown. The patient was administered RECOMBIVAX HB that was exposed to an unsupported temperature excursion. No adverse effect was reported. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Gait disturbance, Injection site erythema, Injection site swelling
Clinical narrative: S/P flu vaccine x2 days - hx of egg allergy but cleared by allergist to have injection at PCP office. Has had injectable 3x before this. (L) upper leg w/ significant swelling - 31 cm at widest point. Mild redness inner aspect of thigh - on opposite side of injection site; no warmth, non-tender - ambulating w/mild limp - does not appear to be painful.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a healthcare worker (office manager) refers to a 65 year old female patient with no drug reactions or allergies and no pertinent medical history. On 01-NOV-2013, the patient was vaccinated with the first dose of PNEUMOVAX 23, lot # J005071, expiration date: 19-JAN-2015, intramuscular in the left deltoid (dose not reported). Concomitant therapies included AMBIEN CR. Over the next 2 days after receiving her first dose of PNEUMOVAX 23, in November 2013, the patient developed injection site reaction described as swelling and redness in her left deltoid where she was vaccinated. There was no treatment given for adverse events. No laboratory tests were performed. The outcome of swelling and redness in her left deltoid was unknown. The patient sought medical attention, was seen in office. This is one of two reports received from the same source. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Abdominal pain upper, Hypoaesthesia, Injection site anaesthesia, Injection site pain
Clinical narrative: Stomach cramps/upset stomach day vaccine was given and typical soreness at injection site, followed by numbness/tingling of area surrounding injection site and entire (L) arm. Numbness/tingling occurred approx. 3 days after vaccine was administered.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Paraesthesia
Clinical narrative: Stomach cramps/upset stomach day vaccine was given and typical soreness at injection site, followed by numbness/tingling of area surrounding injection site and entire (L) arm. Numbness/tingling occurred approx. 3 days after vaccine was administered.
Age: 49.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Lymphadenopathy, Pain in extremity, Pyrexia
Clinical narrative: Got PNEUMOVAX and Tdap in same arm on 12/3/13. Woke up with a very sore arm, a fever of 103, and a swollen lymph node. His high fever was still there 48 hrs later.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from nurse practitioner refers to a patient of unknown age and gender. On 27-NOV-2013, the patient was vaccinated with an expired dose of VARIVAX (Merck), 0.5 ml, subcutaneous, lot number reported as 1798AA, expiration date 15-NOV-2013. No adverse effects reported. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: ANTH, FLU3
Symptoms: Dysphagia, Dyspnoea, Eye pruritus, Lip swelling, Rubber sensitivity
Clinical narrative: On 25 Nov 2013 she received the anthrax vaccine (AVA) dose #2 and two minutes later developed hives on her neck and arms. Symptoms were relieved within the hour with BENADRYL. With AVA dose #1 (26 Jan 2013), 20 minutes after the injection she developed swelling of lips, tongue heaviness, dysphagia, dyspnea and itchy eyes. It was suspected that she had a latex allergy and vial stopper removed with dose #2. She has appointment with an Allergist. 10/26/2013 Anthrax #2 MIP lot FAV341A.
Age: 42.0
Sex: F
Vaccine: ANTH, FLU3
Symptoms: Tongue disorder
Clinical narrative: On 25 Nov 2013 she received the anthrax vaccine (AVA) dose #2 and two minutes later developed hives on her neck and arms. Symptoms were relieved within the hour with BENADRYL. With AVA dose #1 (26 Jan 2013), 20 minutes after the injection she developed swelling of lips, tongue heaviness, dysphagia, dyspnea and itchy eyes. It was suspected that she had a latex allergy and vial stopper removed with dose #2. She has appointment with an Allergist. 10/26/2013 Anthrax #2 MIP lot FAV341A.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt said arm still very sore after 3 weeks, limited mobility. She stated she felt the injection was given too far back on the arm, not in the center.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient called 11/13/13 reporting of signs/symptoms of red, swollen area that is warm to touch where vaccine was administered on 11/11/13. She did see doctor but no idea as to what the treatment was.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Feeling hot
Clinical narrative: Patient became hot and dizzy. Symptoms lasted about 7 minutes. Patient sat down and drank water.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: Immediately after administering vaccine, patient developed raised area at site of injection - advised to take Ibuprofen - when checked on pt next day, same symptoms.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a pharmacist via company representative referring to a patient of unknown age and gender who on an unknown date, was vaccinated with a dose of ZOSTAVAX (lot # not reported). On an unknown date, the patient experienced silver dollar size red area on the arm where ZOSTAVAX was received that was not around the injection site. The outcome of silver dollar size red area on the arm where ZOSTAVAX was received that was not around the injection site was unknown. The patient contacted the pharmacist. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Influenza like illness, Pain, Pruritus, Pyrexia
Clinical narrative: Mild fever, flu-like symptoms, achiness, itchy eyes and hives face, stomach and upper extremities. Pt. took aspirin for fever and achiness. Hive complete resolves 3-4 days later.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Mild fever, flu-like symptoms, achiness, itchy eyes and hives face, stomach and upper extremities. Pt. took aspirin for fever and achiness. Hive complete resolves 3-4 days later.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Injection site urticaria, Pain
Clinical narrative: Very large welt-like injection site reaction, no rash, started day after pt received vaccine. Minimal pain, but reaction had about 6-7" diameter, also bruised looking.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Pt daughter called 20 days later saying that the pain from the flu shot never go away but got worse. Pt not able to lift arm due to the pain. Pharmacist recommeded pt to go to emergency if pain is severe enough. If not, need to make apt with MD PCP to find out and help with pain.
Age: 66.0
Sex: M
Vaccine: VARZOS, UNK
Symptoms: Rash pruritic
Clinical narrative: Itchy rash over body after 4 days.
Age: 66.0
Sex: M
Vaccine: VARZOS, UNK
Symptoms: Injection site pruritus
Clinical narrative: Itchy rash over body after 4 days.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Tenderness
Clinical narrative: Patient reported having a hand sized red area that was tender to the touch. Also it felt hard in the center. She reported this 3 days after vaccination.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Haematoma, Injected limb mobility decreased, Injection site pain
Clinical narrative: Per Dr "Pain in area of injection with limited motion and painful motion." Per Dr, developed hematoma within minutes of administration and pain and decreased mobility continue, particularly unable to raise arm above shoulder level.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Headache, Nausea, Oropharyngeal pain, Pain
Clinical narrative: Body aches, HA, nausea, fever, sore throat, back pain. Pt to appt and stated onset of symptoms and was adamant it was a reaction to HPV. Family member had the flu and missed 1 wk of school - same symptoms.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Body aches, HA, nausea, fever, sore throat, back pain. Pt to appt and stated onset of symptoms and was adamant it was a reaction to HPV. Family member had the flu and missed 1 wk of school - same symptoms.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to two patients of unknown age and gender. On an unknown date, the two patients were vaccinated with ZOSTAVAX (dose, duration and lot were not reported). On an unknown date, the two patients experienced swelling at the injection site after administration of ZOSTAVAX. The outcome of experienced swelling at the injection site was unknown. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling and itchiness at injection site. It is resolving redness started 12/2/13 swelling and itchiness started 12/3/13.
Age: 31.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Pain, Swelling, Vaccination site cellulitis
Clinical narrative: Cellulitis around vaccination site. Patient stated noticing increased redness, pain, and swelling on the night of Dec 4, 2013. Patient was prescribed Doxycycline 100mg tabs twice a day for 10 days.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse concerning to a female patient of unknown age. Current conditions, medical history and relevant past drug history were not reported. On 26-NOV-2013, the patient was vaccinated with RECOMBIVAX HB, 1 ml, (route and lot # not reported) that was improperly stored but it was not discovered until 27-NOV-2013. Concomitant medication was not reported. On 24-NOV-2013, a temperature excursion involving the vaccine occurred/improperly stored. The reporting nurse stated that the patient denied experiencing an adverse reaction to the vaccine. None relevant laboratory. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLUC3, HEPAB, TDAP
Symptoms: Rash
Clinical narrative: Pt came in 2 days after her vaccination complaining of bumps on her neck, on the right side. The bumps had disappeared within 24 hours.
Sex: M
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed practical nurse refers to a "male patient" of unknown age. On 20-MAY-2002, the patient was vaccinated with his one and only dose of M-M-R II, intramuscularly (indication and lot were not reported) which was six days before his first birthday. No adverse effect reported. The outcome of the events were unknown. Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Pericarditis, Troponin I increased
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 26 November 2013 with additional information received on 02 December 2013. A 22 year-old male subject with no significant past medical history was found to have unspecified acute pericarditis and acute idiopathic pericarditis 14 and 10 days respectively after the subject had received the following vaccines on 18 September 2013: an injection of ACAM2000 (lot number, route and site of administration not reported), TYPHIM VI (lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number and site of administration not reported). On 28 September 2013, the subject was found to have an abnormal ECG and a normal echocardiogram. On 29 September 2013, Troponin I result was abnormal with highest record value of 07.00 ng/ml. Lumbar puncture 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.
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Laboratory test
Clinical narrative: Initial information received from a consumer on 26 November 2013. A male patient (whose age and medical history was not reported) had received a Flu vaccine of unknown manufacturer (batch number, route and site of administration not reported). On an unspecified date, after vaccination the patient developed GBS (Guillain Barre Syndrome). This case considered as serious. Lab investigations and treatment medications were not reported. At the time of this report, the outcome was unknown. List of documents held by sender: none.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Pericarditis, Troponin I
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 26 November 2013. A 24-year-old male subject received the following vaccinations: On 17 October 2013 an injection of ACAM2000 (lot number not reported) and on 27 September 2013 Influenza, live, intranasal (manufacturer and lot number not reported) and FLUZONE Intradermal (lot number not reported). On 31 October 2013, the subject was diagnosed with acute pericarditis, unspecified. The subject had no significant past medical history. On 27 October 2013, the subject had a abnormal echocardiogram and on 04 November 2013, the subject had an abnormal electrocardiogram (ECG). Troponin I results were not available. MRI of the brain, spinal cord and heart as well as a lumbar puncture were not performed. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 47.0
Sex: M
Vaccine: ANTH, FLUN4, SMALL, TYP
Symptoms: Cardiac imaging procedure, Cardiomyopathy, Echocardiogram normal, Electrocardiogram abnormal
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 26 November 2013. A 47 year-old male subject with past medical history of high blood pressure, elevated cholesterol and cardiomyopathy was found to have other primary cardiomyopathy 7 days after the subject had received the following vaccines on 26 September 2013: an injection of ACAM2000 (lot number, route and site of administration not reported), TYPHIM VI (lot number, route and site of administration not reported), FLUMIST (lot number not reported) and Anthrax vaccine (manufacturer, lot number, route and site of administration not reported). On 03 October 2013, the subject had an abnormal ECG. Echocardiogram results and MRI of the heart were not available. Troponin I, Lumbar puncture and MRI of the brain and spinal cord 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.
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Adverse reaction
Clinical narrative: Information has been received from a third party claims administrator for a pharmacy concerning a female patient of unknown age. On an unspecified date the patient was vaccinated with ZOSTAVAX and PNEUMOVAX23 (lot#H021941, 11JUL2014). On 20SEP2013 the patient experienced an adverse reaction (NOS). The outcome of adverse reaction is unknown. Additional information has been requested.
Age: 26.0
Sex: M
Vaccine: FLUN4, SMALL
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Myocarditis, Nuclear magnetic resonance imaging abnormal, Pericardial disease
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 26 November 2013. A 26-year-old male subject received the following vaccinations on 07 October 2013: an injection of ACAM2000 (lot number not reported) and FLUMIST (lot number not reported). On 17 October 2013, the subject was diagnosed with unspecified disease of pericardium and non-specific myocarditis. The subject had no significant past medical history. On 16 October 2013, the subject had an abnormal ECG and on 17 October 2013 the subject had a normal troponin I and abnormal echocardiogram. On 18 October 2013, the subject had an abnormal cardiac MRI. MRI of the brain and spinal cord and spinal tap were not performed. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 26.0
Sex: M
Vaccine: FLUN4, SMALL
Symptoms: Troponin I normal
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 26 November 2013. A 26-year-old male subject received the following vaccinations on 07 October 2013: an injection of ACAM2000 (lot number not reported) and FLUMIST (lot number not reported). On 17 October 2013, the subject was diagnosed with unspecified disease of pericardium and non-specific myocarditis. The subject had no significant past medical history. On 16 October 2013, the subject had an abnormal ECG and on 17 October 2013 the subject had a normal troponin I and abnormal echocardiogram. On 18 October 2013, the subject had an abnormal cardiac MRI. MRI of the brain and spinal cord and spinal tap were not performed. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist referring to a female patient of unknown age who on 20-NOV-2013, was vaccinated with a dose of ZOSTAVAX (lot not reported). The pharmacist reported that a patient received ZOSTAVAX and developed a hard, red, painful knot at the injection site. The pharmacist stated that the patient tried to use an over the counter BENADRYL cream, but that it was ineffective for pain and redness. The patient consulted with a nurse "at her work", but no treatment was recommended. The pharmacist stated that she will be filing a VAERS report about this adverse reaction. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Urticaria
Clinical narrative: This spontaneous report was received from a medical assistant via company representative referring to a female patient over 60 years of age who in November 2013 1-2 weeks ago she was vaccinated with a dose of ZOSTAVAX, standard dose, subcutaneously (lot # not reported). In November 2013, after receiving ZOSTAVAX the patient developed hives on her neck and constricted breathing that prompted them to visit the emergency room for treatment. This event occurred 1-2 weeks ago. The vaccine was received by the patient on a Thursday and the patient went to the ER for treatment on the following Sunday. The outcome of hives on her neck and constricted breathing was reported as recovered/resolved on an unspecified date. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Oral herpes
Clinical narrative: This spontaneous report was received from a consumer of an unknown age and gender who reported that on a 20-NOV-2013, was vaccinated with a dose of ZOSTAVAX (lot # not reported). On an unknown date the patient had been having headaches, redness, pain at the site of injection and also got herpes on the lips. The outcome of herpes on the lips, headaches, redness, pain at the site of injection was unknown. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 12 year old female patient. On 27-SEP-2012 the patient was vaccinated with GARDASIL dose 1, intramuscular. Dosing information and lot number were not provided. On 27-SEP-2013 the patient received her second dose of GARDASIL. Dosing information and lot number were not provided. No adverse effect was reported. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test urine positive, Weight increased
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician, concerning a 22 year old female patient with irregular periods. The patient had no known drug reactions/allergies. On 01-MAY-2013 and 19-JUL-2013, the patient was vaccinated with a first and second dose of GARDASIL, 0.5 ml IM, left arm; respectively. On 11-NOV-2013, the patient received the third dose of GARDASIL, 0.5 ml IM, Lot # H019206, expiration date on 03-APR-2015, left arm. It was reported that the patient who was recently vaccinated with her third dose of GARDASIL was pregnant (LMP: 15-OCT-2013; EDD: 22-JUL-2014). The patient had thought she was putting on weight so she took a urine home pregnancy test and it was positive. The patient went to the physician's office to confirm the pregnancy. At the time of the report, the patient's outcome and the relatedness between the suspect therapy and event were unknown. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This report has been received from a nurse, reported that VARIVAX (merck) (lot# H020587, expiration date 13-NOV-2014) and PROQUAD (MARRS# 1311USA012185) were trough unsupported temperature excursions on 26-JUN-2013, 01-JUL-2013, 22-JUL-2013 thru 31-JUL-2013 and the entire month of August 2013. On 15-AUG-2013 the patient was administered the unsupported VARIVAX (merck) (dose and route not reported). This is one of several reports received from the same source (MARRS# 1311USA002616, 1312USA003307, 1312USA003308, 1312USA003309, 1312USA003310, 1312USA003311, 1312USA003312, 1312USA003313, 1312USA003314, 1312USA003315, 1312USA003316, 1312ISA003317). Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This report has been received from the nurse reported that VARIVAX (Merck) (lot # H020587, expiration date 13-NOV-2014) and PROQUAD (MARRS# 1311USA012185) were through unsupported temperature excursions on 26-JUN-2013, 01-JUL-2013 thru 31-JUL-2013 and the entire month of August 2013. On 15-AUg-2013 the patient was administered the unsupported VARIVAX (Merck) (dose and route not reported). This is one of several reports received from the same sourse (MARRS# 1311USA002616, 1312USA003306, 1312USA003308, 1312USA003309, 1312USA003310, 1312USA003311, 1312USA003312, 1312USA003313, 1312USA003314, 1312USA003315, 1312USA003316, 1312USA003317). Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This report has been received from the nurse reported that VARIVAX (merck) (lot# H020587, expiration date 13-NOV-2014) and PROQUAD (MARRS# 1311USA012185) were trough unsupported temperature excursions on 26-JUN-2013, 01-JUL-2013, 22-JUL-2013 thru 31-JUL-2013 and the entire month of August 2013. On 22-AUG-2013 the patient was administered the unsupported VARIVAX (merck) (dose and route not reported). This is one of several reports received from the same source (MARRS# 1311USA002616, 1312USA003306, 1312USA003307, 1312USA003309, 1312USA003310, 1312USA003311, 1312USA003312, 1312USA003313, 1312USA003314, 1312USA003315, 1312USA003316, 1312ISA003317). Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Blood creatine phosphokinase normal, Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture normal, Muscular weakness
Clinical narrative: Progressive bilateral ascending muscular weakness - Guillain-Barre - hosp and rec IVIG. No resp. issues - in PT still recovering started 4 days after Var given.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal
Clinical narrative: Progressive bilateral ascending muscular weakness - Guillain-Barre - hosp and rec IVIG. No resp. issues - in PT still recovering started 4 days after Var given.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This report has been received from the nurse reported that VARIVAX (Merck) (lot # H020587, expiration date 13-NOV-2014) and PROQUAD (Merck) (MARRS# 1311USA012185) were trough unsupported temperature excursions on 26-JUN-2013, 01-JUL-2013, 22-JUL-2013 thru 31-JUL_2013 and the entire month of August 2013. On 23-AUG-2013 the patient was administered the unsupported VARIVAX (Merck) (dose and route not reported). This is one of several reports received from the same source (MARRS# 1311USA002616, 1312USA003307, 1312USA003308, 1312USA003306, 1312USA003310, 1312USA003311, 1312USA003312, 1312USA003313, 1312USA003314, 1312USA003315, 1312USA003316, 1312USA003317). Additional information is not expected.
Age: 34.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Arthralgia
Clinical narrative: She complained of wrist and elbow pain that started a couple days after the injections.  She reported the joint pain on 11/4/13 and it had not yet resolved.  Unknown date of resolution (not reported).
Age: 0.51
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Cerebrovascular accident, Pyrexia
Clinical narrative: Fever had a stroke they were behind giving her vaccine cause her have stroke and she was born her belly keep getting big do to columon plugs or has to have small and large intestine put on out side until grown large get put back in she was one.
Age: 49.0
Sex: M
Vaccine: ANTH
Symptoms: Expired drug administered
Clinical narrative: Patient was given expired medication.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Chest X-ray, Feeling abnormal, Lymphadenopathy, Vaccination complication
Clinical narrative: Pt did not feel good and had swollen lymph nodes.  Mom took her to been seen and was told it was all caused by MCV4 vaccine which she had previously gotten the week before.
Age: 34.0
Sex: F
Vaccine: FLUN4
Symptoms: Activities of daily living impaired, Dizziness, Headache, Migraine, Nausea
Clinical narrative: Developed a headache on 12/2 within hours of receiving the Flumist.  Have had recurrent migraines for the last 3 and a half days leading to dizziness, blurred vision, nausea, vomiting, etc.  Am currently still suffering and have had to miss work.
Age: 34.0
Sex: F
Vaccine: FLUN4
Symptoms: Vision blurred, Vomiting
Clinical narrative: Developed a headache on 12/2 within hours of receiving the Flumist.  Have had recurrent migraines for the last 3 and a half days leading to dizziness, blurred vision, nausea, vomiting, etc.  Am currently still suffering and have had to miss work.
Age: 4.0
Sex: M
Vaccine: FLU3, HEPA, HIBV, MMRV, PNC13
Symptoms: Injection site reaction, Wrong drug administered
Clinical narrative: Pt was given his own vaccinations, on error his siblings vaccinations and possible additional unidentified vaccinations.  Pt has 9-12 site marks.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Large upper torso bilateral rash and hives.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Tenderness
Clinical narrative: Severe pain right knee joint with tenderness.  Pain continues today with decreased intensity due to Motrin and Hot & Cold packs during the night.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash, Rash erythematous
Clinical narrative: Red Rash on Left Neck, Left Hairline. Patient reported some pain (3-4 on pain scale) associated with affected area. Rash appeared, progressed, and then slowly improved with treatment with Valacyclovir 1 gram TID x 7 days initiated on 11/11/13 by Urgent Care.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Antinuclear antibody, C-reactive protein, Full blood count, Headache, Hypoaesthesia
Clinical narrative: Patient states h/a 45 minutes after injection, after nap h/a still constant but not throbbing, she then began to have numbness and tingling in her left arm and leg in which she describes as just a heaviness dullness of sensation in her left upper extremity.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Metabolic function test, Paraesthesia, Red blood cell sedimentation rate, Sensation of heaviness, Sensory disturbance
Clinical narrative: Patient states h/a 45 minutes after injection, after nap h/a still constant but not throbbing, she then began to have numbness and tingling in her left arm and leg in which she describes as just a heaviness dullness of sensation in her left upper extremity.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Eye discharge, Eye swelling, Eyelid oedema, Swelling face, Throat tightness
Clinical narrative: Cheeks and eyes swollen. 10:00 PM  Tightness in throat (no tx required). 7:30 AM 9/25/13 awoke with sticky, swollen eyelids.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site rash, Pain, Rash erythematous
Clinical narrative: Patient states red rash appeared on 11/26/13 and thought it was an exacerbation of his skin dermatitis; however, when the pain began to progress and become more intense and the rash was spreading from his R Shoulder to his R upper arm, R elbox, and R axilla, he suspected it was Shingles and not his skin condition. He sought medical attention at a local clinic. On 11/29 he received a prescription for Valacyclovir 1 gram TID x 7days and hydrocodone/APAP 5-500 1q4-6h prn pain. On 12/11 the patient also received hydrocodone/APAP 5-325 1q4-6h prn pain for unrelieved pain.  He is currently using this medication as well as 600 mg OTC Advil BID prn pain. He states the pain is 10/10 on the pain scale.  He states the rash is still present and that the pain has not yet quelled.
Age: 0.76
Sex: F
Vaccine: FLU3
Symptoms: Blood culture, Crying, Culture wound, Injection site swelling, Pyrexia
Clinical narrative: Patient vaccinated in left leg IM with Flu Vaccine on 11/12/13 at 1:30pm.  Patient went to the ER on 11/18/13 at 9:00pm for a swollen left anterolateral thigh and buttock, fever of 101 F axillary and crying.  Patient was discharged after a few hours with a diagnosis of vaccine reaction and told to follow up with pediatrician.  Patient came to health department at 8:00am on 11/19/13 to follow up because crying was unresolved and the patient's buttock was still swollen.  Patient was referred to the hospital and diagnosed with an abscess due to staph aureus.  The wound was lanced and packed and the child was treated with IV antibiotics.
Age: 0.76
Sex: F
Vaccine: FLU3
Symptoms: Staphylococcal abscess, Swelling, Ultrasound scan, Vaccination complication, Wound drainage
Clinical narrative: Patient vaccinated in left leg IM with Flu Vaccine on 11/12/13 at 1:30pm.  Patient went to the ER on 11/18/13 at 9:00pm for a swollen left anterolateral thigh and buttock, fever of 101 F axillary and crying.  Patient was discharged after a few hours with a diagnosis of vaccine reaction and told to follow up with pediatrician.  Patient came to health department at 8:00am on 11/19/13 to follow up because crying was unresolved and the patient's buttock was still swollen.  Patient was referred to the hospital and diagnosed with an abscess due to staph aureus.  The wound was lanced and packed and the child was treated with IV antibiotics.
Age: 0.76
Sex: F
Vaccine: FLU3
Symptoms: Wound treatment
Clinical narrative: Patient vaccinated in left leg IM with Flu Vaccine on 11/12/13 at 1:30pm.  Patient went to the ER on 11/18/13 at 9:00pm for a swollen left anterolateral thigh and buttock, fever of 101 F axillary and crying.  Patient was discharged after a few hours with a diagnosis of vaccine reaction and told to follow up with pediatrician.  Patient came to health department at 8:00am on 11/19/13 to follow up because crying was unresolved and the patient's buttock was still swollen.  Patient was referred to the hospital and diagnosed with an abscess due to staph aureus.  The wound was lanced and packed and the child was treated with IV antibiotics.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure increased, Flushing, Hyperhidrosis
Clinical narrative: After flu vaccine he became flushed and diaphoretic with a spike in b/p b/p 169/101.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass, Injection site pain, Myalgia, Pain, Pain in extremity
Clinical narrative: This was the double dose and caused lump and sharp pain in left upper arm below injection site. Used heat and cold at first, no help, then doctor visit. Throbbing pain radiating to forearm and shoulder muscle, lasting 7 weeks. Still some pain in forearm and shoulder muscle.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea, Rash erythematous, Rash generalised
Clinical narrative: 20-30 after injection developed a rash over arms, chest neck and face that was red. states she felt very lightheaded and nauseated. Benadryl, Zofran, Pepcid given.
Age: 15.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Blood creatine phosphokinase increased, Injection site pain, Pain, Red blood cell sedimentation rate, Upper respiratory tract infection
Clinical narrative: Received HPV immunizations in right deltoid 11/14/2013.  (Pt was also given influenza vaccine in the left deltoid on the same day.) Since that time has complained of pain in the Right deltoid that has not improved since. It is quite tender to touch, painful with range of motion of arm especially with reaching with the arm. There has been no redness or swelling to the area. Some decrease in pain with Tylenol. Has done some heat to area this week. No fever or other illness symptoms, although did have a URI starting the day after she had the immunization. No numbness or tingling in her arm, no radiation of the pain.
Age: 15.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: X-ray
Clinical narrative: Received HPV immunizations in right deltoid 11/14/2013.  (Pt was also given influenza vaccine in the left deltoid on the same day.) Since that time has complained of pain in the Right deltoid that has not improved since. It is quite tender to touch, painful with range of motion of arm especially with reaching with the arm. There has been no redness or swelling to the area. Some decrease in pain with Tylenol. Has done some heat to area this week. No fever or other illness symptoms, although did have a URI starting the day after she had the immunization. No numbness or tingling in her arm, no radiation of the pain.
Age: 0.33
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Vaccine/Immunization error vaccine given at inappropriate time/age.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cough, Dyspnoea, Eye discharge, Pain
Clinical narrative: Patient had flu shot in the arm 10A by 1130A he had chills, fever, body aches, SOB. Cough, congestion - mattery eyes.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: Patient had flu shot in the arm 10A by 1130A he had chills, fever, body aches, SOB. Cough, congestion - mattery eyes.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Headache, Hyperhidrosis, Injection site erythema, Local reaction
Clinical narrative: Pt developed fever, chills, sweats, headache, severe pain, redness and warmth at the vaccination site, posterior deltoid left arm administered subcutaneously.  This worsened over 3 days.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Vaccination site pain, Vaccination site warmth
Clinical narrative: Pt developed fever, chills, sweats, headache, severe pain, redness and warmth at the vaccination site, posterior deltoid left arm administered subcutaneously.  This worsened over 3 days.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Erythema, no pain nor itching.
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Balance disorder, Blood pressure decreased, Dizziness
Clinical narrative: Patient felt dizzy and lost balance while shopping after getting the vaccines.
Age: 39.0
Sex: M
Vaccine: DTAP
Symptoms: Epistaxis
Clinical narrative: Heavy nosebleed, reoccurring.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram head, Electroencephalogram, Electromyogram, Hypoaesthesia, Laboratory test
Clinical narrative: Leg paralysis, numbness, tingling to hips, legs, hands, neck.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Lumbar puncture, Monoplegia, Nuclear magnetic resonance imaging spinal, Paraesthesia
Clinical narrative: Leg paralysis, numbness, tingling to hips, legs, hands, neck.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Injection site swelling, Oedema mouth
Clinical narrative: This spontaneous report as received from a physician via company representative refers to two patients of unknown age and gender not pregnant. Pertinent medical history and drug reactions/allergies were not reported. On 27-NOV-2013 (reported as a week ago), the patients were vaccinated with VARIVAX (dose, route and lot number were not reported). Other suspect therapies included MMR II. Concomitant therapy was not reported. On 27-NOV-2013, the patients experienced swelling in the mouth and injections site after receiving VARIVAX and MMR II. No lab diagnostics studies were performed. The patients saw the physician. On an unknown date, the patient recovered from the events. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Myalgia
Clinical narrative: Myalgia of left shoulder/trapezius area. Myalgia still noted today (12/6/13), although getting better.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives on abdomen, limbs, and groin. Tx: BENADRYL.
Age: 1.36
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin lesion
Clinical narrative: Erythematous, raised lesions on her trunk 20 minutes after flu vaccination; not itchy; no other symptoms. Resolved with oral ZYRTEC/Ranitidine.
Age: 60.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Paraesthesia
Clinical narrative: Patient began to feel injection site pain 1 hour after shot was administer, which progressed to tingling in arm and hand of injection sight. This lasted for two days after which patient noted reduced range of motion in the affected arm and discovered injection sight was red and swollen.
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. In approximately November 2013 (about a month ago) the patient received ZOSTAVAX (lot number and expiration date not reported) subcutaneous. There was no concomitant medication reported. Shortly after vaccination the patient had an anaphylactic reaction in approximately November 2013. It was reported that the patient sought for medical attention (unspecified medical attention). It was reported that the patient went back to the pharmacy on an unspecified date in 2013 to inform the pharmacist that the was OK. The pharmacist did not assess the seriousness of the event. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Injection site erythema, Injection site pustule, Injection site reaction
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 60 year old or older female patient. Pertinent medical history and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with a single dose of ZOSTAVAX (lot number not provided), 0.65 ml, subcutaneous injection, in the arm. No co-suspect or concomitant therapies were reported. On an unknown date, the patient developed a shingles outbreak at the ZOSTAVAX injection site after vaccination. The area around the site developed pustules and redness. Redness also spread down the arm approximately 2 inches.On an unknown date, the patient recovered from the adverse events. No treatment or lab diagnostics studies were reported. The patient sought medical attention by the office visit. The causality was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a nurse practitioner via a company representative refers to herself an unknown age female patient. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, subcutaneous injection, reported as "standard dose" (lot # was not reported). Concomitant medication was not reported. On an unknown date, the patient developed an injection site rash that was larger than usually that became red, swollen and warm. The reaction lasted for over 1 week. The outcome of the events was reported as recovered. Causality was not reported. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Incorrect dose administered, Viral titre
Clinical narrative: This spontaneous report was received from certificated medical assistant referring to a female patient of unknown age who on 21-NOV-2013, was vaccinated with a dose of MMR II (lot number not reported). Medical assistant reported that the patient who was believed to have been vaccinated with MMR II as a child (unspecified dates/number of doses) had titers drawn for MMR (unspecified date) which came back seronegative for an unspecified component in the vaccine, therefore the patient received a dose of MMR II on 28-MAR-2012. Medical assistant reported that the patient then had MMR titers drawn again on an unspecified date following the administration, which also exhibited seronegative results for an unspecified component in the vaccine. Medical assistant reported that the patient then received another dose of MMR II on 21-NOV-2013. The outcome of titers drawn for MMR that became seronegative for an unspecified component in the vaccine was unknown. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site swelling
Clinical narrative: Information has been received from a certified medical assistant regarding a 23 year old female patient with no drug reactions or allergies. The patient's medical history was unknown. Two years ago, in 2011, the patient was vaccinated with the first two doses of GARDASIL (dose, route and lot number were not provided). Concomitant medication included norgestimate. Now, the patient was at office inquiring if she can receive her third dose. The patient stated she developed swelling around the injection site after she received her second dose. The patient did not receive treatment for the adverse event. Subsequently, the patient recovered. Additional information has been requested.
Age: 36.0
Sex: M
Vaccine: SMALL
Symptoms: Chills, Computerised tomogram head normal, Headache, Nuclear magnetic resonance imaging spinal normal, Pain
Clinical narrative: Patient given vaccinia vacine on 19NOV then deployed on 23NOV, began having symptoms on 29NOV. Patient states he noted body aches, headache, chills but no rash on Friday 29NOV13, then on Saturday 30NOV he noted a small rash on his forearms, which progressed to a pruritic rash over posterior neck, lower forearms, and lower legs.  Rash was raised but not purulent or scaly. The patient was seen by the clinic provider who took the patient to the Hospital. At hospital the patient was evaluated by Neurosurgery, had a brain and C spine MRI performed, both of which were normal with no sign of encephalitis. He was discharged with Acyclovir, Amitryptaline, and Lyrica.  The patient was placed on isolation precautions for 7 days and was maintained in quarantine.  From SAT 30NOV until 06DEC the patient was kept in quarantine with follow up at least twice a day. On Sunday 01DEC, rash was very pruritic and the patient has a small pruritic lesion on the medial sclera of right eye that did not involve the cornea or effect on vision maintaining 20/20 vision in both eyes. The fever symptoms resolved by MON 02DEC, the eye pruritis and lesion resolved by WED 04DEC.  The rash on the forearms and lower legs primarily resolved by 05DEC, the rash on the back of the neck flattened out and became asymptomatic by 06DEC.  At no time were there any open sores, pustules, weeping, scaling, or sloughing of skin.
Age: 36.0
Sex: M
Vaccine: SMALL
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient given vaccinia vacine on 19NOV then deployed on 23NOV, began having symptoms on 29NOV. Patient states he noted body aches, headache, chills but no rash on Friday 29NOV13, then on Saturday 30NOV he noted a small rash on his forearms, which progressed to a pruritic rash over posterior neck, lower forearms, and lower legs.  Rash was raised but not purulent or scaly. The patient was seen by the clinic provider who took the patient to the Hospital. At hospital the patient was evaluated by Neurosurgery, had a brain and C spine MRI performed, both of which were normal with no sign of encephalitis. He was discharged with Acyclovir, Amitryptaline, and Lyrica.  The patient was placed on isolation precautions for 7 days and was maintained in quarantine.  From SAT 30NOV until 06DEC the patient was kept in quarantine with follow up at least twice a day. On Sunday 01DEC, rash was very pruritic and the patient has a small pruritic lesion on the medial sclera of right eye that did not involve the cornea or effect on vision maintaining 20/20 vision in both eyes. The fever symptoms resolved by MON 02DEC, the eye pruritis and lesion resolved by WED 04DEC.  The rash on the forearms and lower legs primarily resolved by 05DEC, the rash on the back of the neck flattened out and became asymptomatic by 06DEC.  At no time were there any open sores, pustules, weeping, scaling, or sloughing of skin.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Arrhythmia, Chest pain, Computerised tomogram thorax, Dyspnoea, Echocardiogram
Clinical narrative: Shortness of breath, chest and shoulder pain, arrhythmia.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging brain
Clinical narrative: Shortness of breath, chest and shoulder pain, arrhythmia.
Age: 24.0
Sex: M
Vaccine: TTOX
Symptoms: Erythema, Hyperaesthesia, Rash papular
Clinical narrative: Around 2 PM, donor stated that he noticed an area on his face approximately 2 inches in size that looked like blemishes, redness noted, and sensitive to touch.  Within a couple hours donor stated that no more symptoms present, completely recovered.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Computerised tomogram, Convulsion, Immunoglobulin therapy, Intensive care
Clinical narrative: Seizure - Status epilepticus hospitalized pediatric ICU for months. Treated with steroids, IVIG, Anti viral meds, antibiotics, AED drugs, medical induced coma.