chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Neck pain, Pain, Paraesthesia, Post herpetic neuralgia, Pruritus
Clinical narrative: This serious medically confirmed spontaneous report (initial receipt 03-Feb-2015) concerns a 59 year-old female patient who was taking concomitant medications of baby aspirin and propafenone for atrial fibrillation. She had received influenza vaccine in the past and unknown if she had received AFLURIA brand previously. She did not have a history of skin reactions or shingles. On 20-Nov-2014, the patient received intramuscular AFLURIA (batch number not provided) from her employer. On an unknown date in Nov-2014, a few days following the vaccination, the patient experienced the symptoms of pain, numbness, tingling, increased sensitivity in her left arm and hand. The pain eventually migrated towards her neck. She sought her primary care provider who ordered a cervical x-ray and prescribed methylprednisolone dose pack. This did not alleviate the neck pain, therefore, her prescription then changed to gabapentin. On the morning of 01-Dec-2014, she noticed blisters on her arm, hand (including palms), wrist and elbow when getting out of the bath tub. There was also a blister under her middle fingernail. On the same day, she revisited her primary care provider who diagnosed her with shingles. She was prescribed valacyclovir 1g daily, gabapentin was changed to pregabalin TID, and hydrocodone 7.5mg daily for pain which she used sparingly. On around 13-Jan-2015, she visited a dermatologist for itchy sores on her forearm. The sores were described as "pimples that keep popping up. Once they heal, they scab over look like craters that were the size of a pencil head". The dermatologist diagnosed her with post herpetic neuralgia and prescribed fluocinonide cream. On 03-Feb-2015, she still had numbness on her palm including her left pinky. The outcome was not recovered.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Scab, Spinal X-ray
Clinical narrative: This serious medically confirmed spontaneous report (initial receipt 03-Feb-2015) concerns a 59 year-old female patient who was taking concomitant medications of baby aspirin and propafenone for atrial fibrillation. She had received influenza vaccine in the past and unknown if she had received AFLURIA brand previously. She did not have a history of skin reactions or shingles. On 20-Nov-2014, the patient received intramuscular AFLURIA (batch number not provided) from her employer. On an unknown date in Nov-2014, a few days following the vaccination, the patient experienced the symptoms of pain, numbness, tingling, increased sensitivity in her left arm and hand. The pain eventually migrated towards her neck. She sought her primary care provider who ordered a cervical x-ray and prescribed methylprednisolone dose pack. This did not alleviate the neck pain, therefore, her prescription then changed to gabapentin. On the morning of 01-Dec-2014, she noticed blisters on her arm, hand (including palms), wrist and elbow when getting out of the bath tub. There was also a blister under her middle fingernail. On the same day, she revisited her primary care provider who diagnosed her with shingles. She was prescribed valacyclovir 1g daily, gabapentin was changed to pregabalin TID, and hydrocodone 7.5mg daily for pain which she used sparingly. On around 13-Jan-2015, she visited a dermatologist for itchy sores on her forearm. The sores were described as "pimples that keep popping up. Once they heal, they scab over look like craters that were the size of a pencil head". The dermatologist diagnosed her with post herpetic neuralgia and prescribed fluocinonide cream. On 03-Feb-2015, she still had numbness on her palm including her left pinky. The outcome was not recovered.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Neck pain, Pain in extremity, Paraesthesia, Post herpetic neuralgia, Pruritus
Clinical narrative: This serious medically confirmed spontaneous report (initial receipt 03-Feb-2015) concerns a 59 year-old female patient who was taking concomitant medications of baby aspirin and propafenone for atrial fibrillation. She had received influenza vaccine in the past and unknown if she had received AFLURIA brand previously. She did not have a history of skin reactions or shingles. On 20-Nov-2014, the patient received intramuscular AFLURIA (batch number not provided) from her employer. On an unknown date in Nov-2014, a few days following the vaccination, the patient experienced the symptoms of pain, numbness, tingling, increased sensitivity in her left arm and hand. The pain eventually migrated towards her neck. She sought her primary care provider who ordered a cervical x-ray and prescribed methylprednisolone dose pack. This did not alleviate the neck pain, therefore, her prescription then changed to gabapentin. On the morning of 01-Dec-2014, she noticed blisters on her arm, hand (including palms), wrist and elbow when getting out of the bath tub. There was also a blister under her middle fingernail. On the same day, she revisited her primary care provider who diagnosed her with shingles. She was prescribed valacyclovir 1g daily, gabapentin was changed to pregabalin TID, and hydrocodone 7.5mg daily for pain which she used sparingly. On around 13-Jan-2015, she visited a dermatologist for itchy sores on her forearm. The sores were described as "pimples that keep popping up. Once they heal, they scab over look like craters that were the size of a pencil head". The dermatologist diagnosed her with post herpetic neuralgia and prescribed fluocinonide cream. On 03-Feb-2015, she still had numbness on her palm including her left pinky. The outcome was not recovered.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Scab, Skin ulcer
Clinical narrative: This serious medically confirmed spontaneous report (initial receipt 03-Feb-2015) concerns a 59 year-old female patient who was taking concomitant medications of baby aspirin and propafenone for atrial fibrillation. She had received influenza vaccine in the past and unknown if she had received AFLURIA brand previously. She did not have a history of skin reactions or shingles. On 20-Nov-2014, the patient received intramuscular AFLURIA (batch number not provided) from her employer. On an unknown date in Nov-2014, a few days following the vaccination, the patient experienced the symptoms of pain, numbness, tingling, increased sensitivity in her left arm and hand. The pain eventually migrated towards her neck. She sought her primary care provider who ordered a cervical x-ray and prescribed methylprednisolone dose pack. This did not alleviate the neck pain, therefore, her prescription then changed to gabapentin. On the morning of 01-Dec-2014, she noticed blisters on her arm, hand (including palms), wrist and elbow when getting out of the bath tub. There was also a blister under her middle fingernail. On the same day, she revisited her primary care provider who diagnosed her with shingles. She was prescribed valacyclovir 1g daily, gabapentin was changed to pregabalin TID, and hydrocodone 7.5mg daily for pain which she used sparingly. On around 13-Jan-2015, she visited a dermatologist for itchy sores on her forearm. The sores were described as "pimples that keep popping up. Once they heal, they scab over look like craters that were the size of a pencil head". The dermatologist diagnosed her with post herpetic neuralgia and prescribed fluocinonide cream. On 03-Feb-2015, she still had numbness on her palm including her left pinky. The outcome was not recovered.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Allergy to vaccine, Blister, Erythema, Pruritus, Tenderness
Clinical narrative: Pt presented to PHN to report redness, tenderness, itching. Pt had wheal that measured 3.4x4.8cm and is raised with some small scattered vesicles noted throughout. Pt denies fever or warmth to area. PHN contacted medical director, who ordered to not give 2nd dose of varicella vaccine to pt. Dr. states pt must be allergic to the vaccine.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Pt presented to PHN to report redness, tenderness, itching. Pt had wheal that measured 3.4x4.8cm and is raised with some small scattered vesicles noted throughout. Pt denies fever or warmth to area. PHN contacted medical director, who ordered to not give 2nd dose of varicella vaccine to pt. Dr. states pt must be allergic to the vaccine.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Haematoma, Injected limb mobility decreased, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: R upper arm pain, swelling, firmness, warmth, difficulty moving the arm due to pain.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Ultrasound scan abnormal
Clinical narrative: R upper arm pain, swelling, firmness, warmth, difficulty moving the arm due to pain.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary mass, Axillary pain, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: I am an RN and also the patient. I noticed pain in my right axilla approx 30 hours after recieving vaccine. I visually examined and palated enlarged lymph nodes in axilla, forming a lump approximately 3 cm in diameter in my axilla, same arm where vaccine was recieved.  In the injection site, I observed a red welt-like swollen area that was approximately 5 cm in diameter. Today, 7 days after the vaccine was obtained, the axilla pain and lymph node swelling is now completely resolved, and the vaccine site reaction is mostly resolved.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymph node palpable, Lymphadenopathy, Urticaria
Clinical narrative: I am an RN and also the patient. I noticed pain in my right axilla approx 30 hours after recieving vaccine. I visually examined and palated enlarged lymph nodes in axilla, forming a lump approximately 3 cm in diameter in my axilla, same arm where vaccine was recieved.  In the injection site, I observed a red welt-like swollen area that was approximately 5 cm in diameter. Today, 7 days after the vaccine was obtained, the axilla pain and lymph node swelling is now completely resolved, and the vaccine site reaction is mostly resolved.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation, Decreased appetite, Erythema, Lymphadenopathy, Malaise
Clinical narrative: Reports swollen glands along left neck. Bright red burning hives all over face, from above eyebrows to jawline. Followed by 6-7 weeks of malaise, night sweats, and loss of appetite. Still has red patches on face.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Night sweats, Urticaria
Clinical narrative: Reports swollen glands along left neck. Bright red burning hives all over face, from above eyebrows to jawline. Followed by 6-7 weeks of malaise, night sweats, and loss of appetite. Still has red patches on face.
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Influenza virus test
Clinical narrative: Information was received for this unsolicited report on 09 February 2015 from a consumer who is the patient's mother. This reporter also reported two other events, one for her husband and one for herself. These cases are captured in 2014SA172624 and 2015SA017179. A female patient, with an unknown medical history, age and date of birth not reported was vaccinated at a pediatrician's office on an unknown date with Influenza vaccine, manufacturer, batch, route and site of administration were not reported. The patient was seen at the ER last night (08 February 2015) and was swabbed and has the Flu now too. The reporter was not sure which vaccine she received. She will report  it once she finds out. Laboratory test was not provided. The patient outcome is unknown. Documents held by sender: None.
Sex: F
Vaccine: FLUX
Symptoms: Influenza virus test positive, Malaise
Clinical narrative: Information was received for this unsolicited report on 09 February 2015 from a consumer who is the patient. This reporter also reported two other events, one for her husband and one for her infant. These cases are captured in 2014SA172624 and 2015SA017180. A female patient with an unknown medical history was vaccinated with Influenza vaccine, manufacturer, batch, route and site of administration were not reported on an unknown date. On Wednesday last week (04 February 2015), the patient began to get sick and on Thursday she went to the doctor. She was swabbed and she found out today that she tested positive for the Flu. Laboratory test was not provided. She was vaccinated at the same time as her husband at the clinic and feels that she would have had the same vaccine as her husband. She has requested the information from the health clinic and will report it once she has received the information. The patient outcome was not reported. Documents held by sender: None.
Age: 1.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Condition aggravated, Febrile convulsion
Clinical narrative: Initial unsolicited case received from a consumer, who is also the patient's mother, on 10 February 2015. An 18-month-old-male patient, with a history of febrile seizures, received a third left thigh injection of PENTACEL (lot number not reported) on 11 January 2015. Information for the first two doses was not provided. The patient was not ill at the time of vaccination. One day post-vaccination, on 12 January 2015, the patient had a febrile seizure. The patient's family called for emergency services, and upon arrival the medics applied oxygen; however the patient had already recovered. The reporter stated that she refused treatment for the patient, since he had a history of febrile seizure. She also noted that the patient had not received TYLENOL post-vaccination. Documents held by sender: None.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Inflammation, Pain in extremity, Skin warm
Clinical narrative: Patient came into pharmacy on 2/18/2015 showing me her right arm.  It was hot, red, inflamed and she states pain.  She also received the flu vaccine the same day she received the Prevnar.  Confirmed that Prevnar was given in her right arm and that is was the vaccine causing the reaction.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. On 13-FEB-2015 the patient was vaccinated with a dose of ROTATEQ oral, (dose and lot # not reported) that had undergone temperature excursions. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. On 10-FEB-2015 the patient was vaccinated with a dose of ROTATEQ oral (dose and lot # not reported) that had undergone temperature excursions. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. On 09-FEB-2015 the patient was vaccinated with a dose of ROTATEQ (dose and lot # not reported) that had undergone temperature excursions. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. On 06-FEB-2015 the patient was vaccinated with a dose of ROTATEQ oral (dose and lot # not reported) that had undergone temperature excursions. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 99.0
Sex: F
Vaccine: PPV
Symptoms: Cardiac arrest, Confusional state, Death, Nausea, Pulse absent
Clinical narrative: 99 y/o female w/ IHD, OA came to office for Wellness exam.  Doing well, no c/o's. Was given a Pneumovax in right deltoid. Was told by son she was active w/ walker the rest of the day.  Ate lunch and dinner well.  Developed nausea, vomiting at 11PM. Became confused.  Paramedics called.  Caretaker found a pulse but paramedics did not. Pt taken to ED but was pulseless and asystolic on arrival. Pronounced dead around 12:25AM.
Age: 99.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: 99 y/o female w/ IHD, OA came to office for Wellness exam.  Doing well, no c/o's. Was given a Pneumovax in right deltoid. Was told by son she was active w/ walker the rest of the day.  Ate lunch and dinner well.  Developed nausea, vomiting at 11PM. Became confused.  Paramedics called.  Caretaker found a pulse but paramedics did not. Pt taken to ED but was pulseless and asystolic on arrival. Pronounced dead around 12:25AM.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea, Fatigue, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: Diarrhea 4 to 5 times per day starting 5 hours post injection, and hasn't stopped yet. Fever 11 days post injection. Child is easily tired and complaining of pain in legs.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Impaired driving ability, Injected limb mobility decreased, Insomnia, Pain
Clinical narrative: At first, I thought my arm was just sore from injection.  However, it got much worse throughout the day and I had much difficulty using my left arm (where injection was given.) I was unable to dress, drive, moving certain ways brought such severe pain, I could not function.  Pain to tears.  I have never had arm or shoulder pain.  If the arm stayed still, it did not hurt.  Any movement in certain ways brought on severe pain that would last for several minutes.  The months of November and December, I took Aleve & Advil and rubbed my arm with sports creams.  Late December, I asked my physician for guidance and we decided on Physical Therapy.  I went to Rehab and they evaluated me and treated with exercise, steroid patch, and some sort of pulse therapy-Also steroid cream.  Also, I had great difficulty sleeping.  That lasted through January.  Had I had a job with manual labor, I would not have been able to work.  Thankfully, I was able to function, and am now much improved-probably 80% back to norman.  I spent close to $1000 at physical therapy, as my deductible had not been met.  I had no health issues before this and would consider myself to be in excellent health.  The pharmacist who administered the vaccination took his time and seemed to know exactly what he was doing.  I, in no way, blame him.  Something went absolutely wrong thought and I do feel the need to report this.  I am very RELUCTANT to receive any more shots in my arm.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: At first, I thought my arm was just sore from injection.  However, it got much worse throughout the day and I had much difficulty using my left arm (where injection was given.) I was unable to dress, drive, moving certain ways brought such severe pain, I could not function.  Pain to tears.  I have never had arm or shoulder pain.  If the arm stayed still, it did not hurt.  Any movement in certain ways brought on severe pain that would last for several minutes.  The months of November and December, I took Aleve & Advil and rubbed my arm with sports creams.  Late December, I asked my physician for guidance and we decided on Physical Therapy.  I went to Rehab and they evaluated me and treated with exercise, steroid patch, and some sort of pulse therapy-Also steroid cream.  Also, I had great difficulty sleeping.  That lasted through January.  Had I had a job with manual labor, I would not have been able to work.  Thankfully, I was able to function, and am now much improved-probably 80% back to norman.  I spent close to $1000 at physical therapy, as my deductible had not been met.  I had no health issues before this and would consider myself to be in excellent health.  The pharmacist who administered the vaccination took his time and seemed to know exactly what he was doing.  I, in no way, blame him.  Something went absolutely wrong thought and I do feel the need to report this.  I am very RELUCTANT to receive any more shots in my arm.
Age: 82.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site vesicles
Clinical narrative: Patient has an injection site reaction that is still affecting him at this time.  The site is red, "bubbly", and tender to the touch.  The patient states he has been demonstrating this same symptoms since the vaccine was administered in October.  The patient's wife also states the patient has been unusually fatigued since the vaccine's administration.  I talked to the patient today (2/18/15) and referred him to his primary physician.
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness
Clinical narrative: LIGHTHEADEDNESS, FOLLOWING DONATION, AND IMMUNIZATION. DNR SAT IN CHAIR FOR 5 MINUTES, POWERADE GIVEN 16.9 OZ., RECOVERED.
Age: 1.02
Sex: M
Vaccine: DTAPH, MMRV
Symptoms: Fatigue, Pyrexia, Screaming
Clinical narrative: Unusual high pitched screaming that lasted for several hours, followed by extreme exhaustion and high fever (103F) that lasted for approximately twelve hours afterwards.
Age: 8.0
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Patent broke out in a rash one week after receiving the MMR vaccine. Vaccine administered on 02/06/2015. Rash appeared on 02/15/2015.
Age: 1.31
Sex: F
Vaccine: DTAP, FLU4, PNC13
Symptoms: Wrong drug administered
Clinical narrative: Wrong vaccine was given.
Age: 3.0
Sex: M
Vaccine: DTAPIPV, HEPA, HIBV, MMRV
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Mother sts pt has a red, itchy, rash at the site of administration, left deltoid.  Per the mother pt has been administered Benadryl for the past two days on as of today, 2/18/2015, the site is clearing up.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: CSF cell count normal, CSF protein increased, CSF white blood cell count negative, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Ascending paralysis and numbness consistent with Guillain Barre Syndrome.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: SKIN RED AND ITCHING IN AREA OF SHOT.
Age: 53.0
Sex: F
Vaccine: TTOX
Symptoms: Drug administered at inappropriate site, Injection site injury, Pain
Clinical narrative: Shoulder injury due to vaccine administration. Shot hit bone and resulted in rotator cuff pain and pain using left arm.  Shot given too high into bursa instead of muscle.
Sex: M
Vaccine: VARCEL
Symptoms: Mobility decreased, Speech disorder, Vaccination complication
Clinical narrative: This spontaneous report was received from a mother of patient refers to her son of unknown age. Concurrent conditions and medical history was not reported. On an unknown date, the patient was vaccinated with VARIVAX (Merck) injection (dose, route, lot number were not reported). Concomitant medications were not reported. On an unknown date, the patient lost movement in his leg (hospitalization) after receiving VARIVAX (Merck). On an unknown date, the patient was taken to an unspecified hospital (duration/location unknown) where an unspecified health care professional said this was a side effect of VARIVAX (Merck). Also reported the patient received therapy and has regained most usage of his leg but he can't verbalize (medically significant) if he was in pain or having difficulty with the limb. The outcome of the events was unknown. Causality was not assessed by the reporter. Upon internal review the event of can't verbalize was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. On 11-FEB-2015 the patient was vaccinated with a dose of ROTATEQ oral (dose and lot # not reported) that had undergone temperature excursions. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.25
Sex: F
Vaccine: DTAP, RV5
Symptoms: Urticaria, Vaccination complication
Clinical narrative: Infant developed hives over entire body approx. 5 1/2 hours after receiving her vaccines. BENADRYL was given 2 x that evening for hives. This morning hives resolved and no further reaction. Infant evaluated in office at 9:30 am (2/18/15) and diagnosed with vaccine reaction.
Age: 59.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Skin reaction, Vaccination site reaction
Clinical narrative: Localized skin reaction at vaccine administration site zoster site (L) posterior upper arm. Treated with BENADRYL and KEFLEX to cover for possible cellulitis.
Age: 1.58
Sex: F
Vaccine: DTAP, FLU3, HEPA, HIBV, PNC13
Symptoms: Decreased appetite, Fear of falling, Feeding tube user, Feeling abnormal, Injection site erythema
Clinical narrative: Fever, redness and swelling at injection sites, fussy, irritable, fear of falling, zoning out, decreased eating (although still takes bottles) but have to go back to tube feeds for enough calories through her g-tube and to prevent dehydration.
Age: 1.58
Sex: F
Vaccine: DTAP, FLU3, HEPA, HIBV, PNC13
Symptoms: Injection site swelling, Irritability, Pyrexia
Clinical narrative: Fever, redness and swelling at injection sites, fussy, irritable, fear of falling, zoning out, decreased eating (although still takes bottles) but have to go back to tube feeds for enough calories through her g-tube and to prevent dehydration.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Ear pain, Mobility decreased, Musculoskeletal discomfort
Clinical narrative: Pt woke up the next morning with ear ache. Woke up another day and thought she had a crick in her neck. GOt to where she couldn't move her shoulder. Is seeing dr.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Condition aggravated, Intervertebral disc protrusion, Mobility decreased
Clinical narrative: Patient states on 2/7/15 had severe chills, body aches, sore joints. It affected her bulging discs in her spine and she could not move at all that day.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: Patient states on 2/7/15 had severe chills, body aches, sore joints. It affected her bulging discs in her spine and she could not move at all that day.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Erythema multiforme, Rash
Clinical narrative: Pt. developed rash c/w erythema multiforme 6-8 after injection.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of drug administration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate route of vaccination in a 26-year-old female patient who received FLULAVAL QUADRIVALENT (batch number AR57J, expiry date 31st May 2015). On an unknown date, the patient received FLULAVAL QUADRIVALENT (intravenous). On an unknown date, an unknown time after receiving FLULAVAL QUADRIVALENT, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the inappropriate route of vaccination was unknown. Additional information: the vaccine was given IV instead of IM.
Sex: U
Vaccine: RV1
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a nurse vial call center representative and described the occurrence of inappropriate age at vaccine administration in a unk patient who received ROTARIX (batch number A41CB403A, expiry date 3rd September 2015). On an unknown date, the patient received ROTARIX. On an unknown time after receiving ROTARIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information: A 9 month old was administered ROTARIX. RN did not want to give any further information.
Age: 0.88
Sex: M
Vaccine: FLUX, RV5, FLUX, RV5
Symptoms: Allergy test, Blood test, Decreased eye contact, Feeling of despair, Gastrointestinal disorder
Clinical narrative: This spontaneous report as received from the patient's mother refers to her currently 2 years old male son, who cannot tolerate corn, had acid reflux and is allergic to corn and acetaminophen. On an unknown date in fall 2013, the patient was vaccinated with ROTATEQ, oral, (lot number and expiration date were not reported) along with an unspecified influenza virus vaccine (manufacturer unknown). Concomitant therapies included ZANTAC. On an unspecified date, after receiving both vaccines, the patient became despondent, could not make eye contact and developed various gastrointestinal and neurological issues that lasted 34 days. The patient's mother sought unspecified medical attention and some of laboratories were performed: Blood levels, allergy scratch test, allergy antibodies test (results were not provided). No treatment was given for the events. The reporter stated that according to her physician, the patient cannot receive more than one vaccine at a time or the same reactions would occur. The patient's son had a twin brother that did not have this condition, but had autism. The patient present status was reported as recovered (date was not specified). Additional information has been requested.
Age: 0.88
Sex: M
Vaccine: FLUX, RV5, FLUX, RV5
Symptoms: Nervous system disorder, Skin test
Clinical narrative: This spontaneous report as received from the patient's mother refers to her currently 2 years old male son, who cannot tolerate corn, had acid reflux and is allergic to corn and acetaminophen. On an unknown date in fall 2013, the patient was vaccinated with ROTATEQ, oral, (lot number and expiration date were not reported) along with an unspecified influenza virus vaccine (manufacturer unknown). Concomitant therapies included ZANTAC. On an unspecified date, after receiving both vaccines, the patient became despondent, could not make eye contact and developed various gastrointestinal and neurological issues that lasted 34 days. The patient's mother sought unspecified medical attention and some of laboratories were performed: Blood levels, allergy scratch test, allergy antibodies test (results were not provided). No treatment was given for the events. The reporter stated that according to her physician, the patient cannot receive more than one vaccine at a time or the same reactions would occur. The patient's son had a twin brother that did not have this condition, but had autism. The patient present status was reported as recovered (date was not specified). Additional information has been requested.
Age: 0.88
Sex: M
Vaccine: FLUX, RV5, FLUX, RV5
Symptoms: Allergy test, Antibody test, Blood test, Decreased eye contact, Feeling of despair
Clinical narrative: This spontaneous report as received from the patient's mother refers to her currently 2 years old male son, who cannot tolerate corn, had acid reflux and is allergic to corn and acetaminophen. On an unknown date in fall 2013, the patient was vaccinated with ROTATEQ, oral, (lot number and expiration date were not reported) along with an unspecified influenza virus vaccine (manufacturer unknown). Concomitant therapies included ZANTAC. On an unspecified date, after receiving both vaccines, the patient became despondent, could not make eye contact and developed various gastrointestinal and neurological issues that lasted 34 days. The patient's mother sought unspecified medical attention and some of laboratories were performed: Blood levels, allergy scratch test, allergy antibodies test (results were not provided). No treatment was given for the events. The reporter stated that according to her physician, the patient cannot receive more than one vaccine at a time or the same reactions would occur. The patient's son had a twin brother that did not have this condition, but had autism. The patient present status was reported as recovered (date was not specified). Additional information has been requested.
Age: 0.88
Sex: M
Vaccine: FLUX, RV5, FLUX, RV5
Symptoms: Gastrointestinal disorder, Nervous system disorder, Skin test
Clinical narrative: This spontaneous report as received from the patient's mother refers to her currently 2 years old male son, who cannot tolerate corn, had acid reflux and is allergic to corn and acetaminophen. On an unknown date in fall 2013, the patient was vaccinated with ROTATEQ, oral, (lot number and expiration date were not reported) along with an unspecified influenza virus vaccine (manufacturer unknown). Concomitant therapies included ZANTAC. On an unspecified date, after receiving both vaccines, the patient became despondent, could not make eye contact and developed various gastrointestinal and neurological issues that lasted 34 days. The patient's mother sought unspecified medical attention and some of laboratories were performed: Blood levels, allergy scratch test, allergy antibodies test (results were not provided). No treatment was given for the events. The reporter stated that according to her physician, the patient cannot receive more than one vaccine at a time or the same reactions would occur. The patient's son had a twin brother that did not have this condition, but had autism. The patient present status was reported as recovered (date was not specified). Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Induration, Joint range of motion decreased, Peripheral swelling, Skin infection, Skin mass
Clinical narrative: This spontaneous report was received from a physician refers to a 61 year old female patient with multiple sclerosis, pre diabetes, hyperlipidemia, Chronic back pain and allergic reaction to penicillin, gemfibrozil and cortisone. On 31-DEC-2014, the patient was vaccinated with ZOSTAVAX VIAL 19400 PFU injection (lot # K010969 and expiration date November 2015) (strength, dose and route were not reported) for prevention of shingles. Concomitant therapies included aspirin, hydrocodone as needed and estradiol patch (unspecified doses/frequencies and manufacturers). On 31-DEC-2014, the patient experienced red fevery swelling that has spread from her shoulder to her elbow and painful swelling of her collar bone that is affecting the movements of her arm after receiving zoster vaccine live. On an unknown date approximately in 2015 (several days later), the patient developed redness and swelling at the injection site in her right arm. Several days after that on an unknown date approximately in 2015, the patient developed swelling in sternoclavicular joint on the same side as her injection. Lab tests includes X-ray, CAT scan, Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), erythrocyte sedimentation rate and the results were unknown. MRI performed on 06-FEB-2015 and Bone scan performed on unspecified date showed inflammation & swelling of right sternoclavicular joint. Blood tests not revealed any abnormalities. No Product Quality Complaint (PQC) was involved. On 09-JAN-2015, the patient sought medical attention by an office visit. The patient treated with unspecified antibiotic tablets (unspecified manufacturer) 500 mg/3 times daily. The physician prescribed some medication cephalexin and meloxicam to treat the patient symptoms and they seemed to help minimally. The physician reported that the patient is scheduled to have a biopsy of the swollen area at a future date. Action taken with the therapy of zoster vaccine live was not applicable. The outcome of events was reported as not recovered/not resolved. Causality was not assessed by the reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin warm, Swelling
Clinical narrative: This spontaneous report was received from a physician refers to a 61 year old female patient with multiple sclerosis, pre diabetes, hyperlipidemia, Chronic back pain and allergic reaction to penicillin, gemfibrozil and cortisone. On 31-DEC-2014, the patient was vaccinated with ZOSTAVAX VIAL 19400 PFU injection (lot # K010969 and expiration date November 2015) (strength, dose and route were not reported) for prevention of shingles. Concomitant therapies included aspirin, hydrocodone as needed and estradiol patch (unspecified doses/frequencies and manufacturers). On 31-DEC-2014, the patient experienced red fevery swelling that has spread from her shoulder to her elbow and painful swelling of her collar bone that is affecting the movements of her arm after receiving zoster vaccine live. On an unknown date approximately in 2015 (several days later), the patient developed redness and swelling at the injection site in her right arm. Several days after that on an unknown date approximately in 2015, the patient developed swelling in sternoclavicular joint on the same side as her injection. Lab tests includes X-ray, CAT scan, Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), erythrocyte sedimentation rate and the results were unknown. MRI performed on 06-FEB-2015 and Bone scan performed on unspecified date showed inflammation & swelling of right sternoclavicular joint. Blood tests not revealed any abnormalities. No Product Quality Complaint (PQC) was involved. On 09-JAN-2015, the patient sought medical attention by an office visit. The patient treated with unspecified antibiotic tablets (unspecified manufacturer) 500 mg/3 times daily. The physician prescribed some medication cephalexin and meloxicam to treat the patient symptoms and they seemed to help minimally. The physician reported that the patient is scheduled to have a biopsy of the swollen area at a future date. Action taken with the therapy of zoster vaccine live was not applicable. The outcome of events was reported as not recovered/not resolved. Causality was not assessed by the reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthritis, Blood test normal, Bone scan abnormal, Computerised tomogram, Erythema
Clinical narrative: This spontaneous report was received from a physician refers to a 61 year old female patient with multiple sclerosis, pre diabetes, hyperlipidemia, Chronic back pain and allergic reaction to penicillin, gemfibrozil and cortisone. On 31-DEC-2014, the patient was vaccinated with ZOSTAVAX VIAL 19400 PFU injection (lot # K010969 and expiration date November 2015) (strength, dose and route were not reported) for prevention of shingles. Concomitant therapies included aspirin, hydrocodone as needed and estradiol patch (unspecified doses/frequencies and manufacturers). On 31-DEC-2014, the patient experienced red fevery swelling that has spread from her shoulder to her elbow and painful swelling of her collar bone that is affecting the movements of her arm after receiving zoster vaccine live. On an unknown date approximately in 2015 (several days later), the patient developed redness and swelling at the injection site in her right arm. Several days after that on an unknown date approximately in 2015, the patient developed swelling in sternoclavicular joint on the same side as her injection. Lab tests includes X-ray, CAT scan, Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), erythrocyte sedimentation rate and the results were unknown. MRI performed on 06-FEB-2015 and Bone scan performed on unspecified date showed inflammation & swelling of right sternoclavicular joint. Blood tests not revealed any abnormalities. No Product Quality Complaint (PQC) was involved. On 09-JAN-2015, the patient sought medical attention by an office visit. The patient treated with unspecified antibiotic tablets (unspecified manufacturer) 500 mg/3 times daily. The physician prescribed some medication cephalexin and meloxicam to treat the patient symptoms and they seemed to help minimally. The physician reported that the patient is scheduled to have a biopsy of the swollen area at a future date. Action taken with the therapy of zoster vaccine live was not applicable. The outcome of events was reported as not recovered/not resolved. Causality was not assessed by the reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Full blood count, Injection site erythema, Injection site swelling, Metabolic function test, Mobility decreased
Clinical narrative: This spontaneous report was received from a physician refers to a 61 year old female patient with multiple sclerosis, pre diabetes, hyperlipidemia, Chronic back pain and allergic reaction to penicillin, gemfibrozil and cortisone. On 31-DEC-2014, the patient was vaccinated with ZOSTAVAX VIAL 19400 PFU injection (lot # K010969 and expiration date November 2015) (strength, dose and route were not reported) for prevention of shingles. Concomitant therapies included aspirin, hydrocodone as needed and estradiol patch (unspecified doses/frequencies and manufacturers). On 31-DEC-2014, the patient experienced red fevery swelling that has spread from her shoulder to her elbow and painful swelling of her collar bone that is affecting the movements of her arm after receiving zoster vaccine live. On an unknown date approximately in 2015 (several days later), the patient developed redness and swelling at the injection site in her right arm. Several days after that on an unknown date approximately in 2015, the patient developed swelling in sternoclavicular joint on the same side as her injection. Lab tests includes X-ray, CAT scan, Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), erythrocyte sedimentation rate and the results were unknown. MRI performed on 06-FEB-2015 and Bone scan performed on unspecified date showed inflammation & swelling of right sternoclavicular joint. Blood tests not revealed any abnormalities. No Product Quality Complaint (PQC) was involved. On 09-JAN-2015, the patient sought medical attention by an office visit. The patient treated with unspecified antibiotic tablets (unspecified manufacturer) 500 mg/3 times daily. The physician prescribed some medication cephalexin and meloxicam to treat the patient symptoms and they seemed to help minimally. The physician reported that the patient is scheduled to have a biopsy of the swollen area at a future date. Action taken with the therapy of zoster vaccine live was not applicable. The outcome of events was reported as not recovered/not resolved. Causality was not assessed by the reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nuclear magnetic resonance imaging abnormal, Peripheral swelling, Red blood cell sedimentation rate, Skin warm, X-ray
Clinical narrative: This spontaneous report was received from a physician refers to a 61 year old female patient with multiple sclerosis, pre diabetes, hyperlipidemia, Chronic back pain and allergic reaction to penicillin, gemfibrozil and cortisone. On 31-DEC-2014, the patient was vaccinated with ZOSTAVAX VIAL 19400 PFU injection (lot # K010969 and expiration date November 2015) (strength, dose and route were not reported) for prevention of shingles. Concomitant therapies included aspirin, hydrocodone as needed and estradiol patch (unspecified doses/frequencies and manufacturers). On 31-DEC-2014, the patient experienced red fevery swelling that has spread from her shoulder to her elbow and painful swelling of her collar bone that is affecting the movements of her arm after receiving zoster vaccine live. On an unknown date approximately in 2015 (several days later), the patient developed redness and swelling at the injection site in her right arm. Several days after that on an unknown date approximately in 2015, the patient developed swelling in sternoclavicular joint on the same side as her injection. Lab tests includes X-ray, CAT scan, Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), erythrocyte sedimentation rate and the results were unknown. MRI performed on 06-FEB-2015 and Bone scan performed on unspecified date showed inflammation & swelling of right sternoclavicular joint. Blood tests not revealed any abnormalities. No Product Quality Complaint (PQC) was involved. On 09-JAN-2015, the patient sought medical attention by an office visit. The patient treated with unspecified antibiotic tablets (unspecified manufacturer) 500 mg/3 times daily. The physician prescribed some medication cephalexin and meloxicam to treat the patient symptoms and they seemed to help minimally. The physician reported that the patient is scheduled to have a biopsy of the swollen area at a future date. Action taken with the therapy of zoster vaccine live was not applicable. The outcome of events was reported as not recovered/not resolved. Causality was not assessed by the reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Blood pressure abnormal, Confusional state, Dizziness, Dyskinesia, Electrocardiogram normal
Clinical narrative: This spontaneous report as received from a licensed practical nurse via company representative, refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a first dose of GARDASIL (dose, route, lot# and expiration date were not reported). On an unknown date the patient was taken to emergency room (ER) (location and duration unknown) for unknown reasons. The outcome of the event was not reported. Relatedness between the event and GARDASIL was not provided. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Pallor, Vomiting
Clinical narrative: This spontaneous report as received from a licensed practical nurse via company representative, refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a first dose of GARDASIL (dose, route, lot# and expiration date were not reported). On an unknown date the patient was taken to emergency room (ER) (location and duration unknown) for unknown reasons. The outcome of the event was not reported. Relatedness between the event and GARDASIL was not provided. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Pallor
Clinical narrative: This spontaneous report as received from a licensed practical nurse via company representative, refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a first dose of GARDASIL (dose, route, lot# and expiration date were not reported). On an unknown date the patient was taken to emergency room (ER) (location and duration unknown) for unknown reasons. The outcome of the event was not reported. Relatedness between the event and GARDASIL was not provided. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse via company representative, refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a first dose of GARDASIL (dose, route, lot# and expiration date were not reported). On an unknown date the patient was taken to emergency room (ER) (location and duration unknown) for unknown reasons. The outcome of the event was not reported. Relatedness between the event and GARDASIL was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored ZOSTAVAX (route, dose, lot number and expiration date were not provided). Concomitant medications were not reported. No adverse effects were reported and there was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.