chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site pruritus
Clinical narrative: This spontaneous report as received from a consumer refers to his 67 year old wife with no pertinent medical history, drug reactions or allergies. On 02-DEC-2013 (also reported as 4 weeks ago), the patient was vaccinated with ZOSTAVAX, intramuscular (dose, strength and lot number were not reported). There was no concomitant medications. On 02-DEC-2013, the patient was concerned about the efficacy of the vaccine, since she was sure that the shot was given to her intramuscularly. The consumer reported that his wife experienced itching at the injection site, later in the evening after getting the shot and the itching continued for the next couple of days. The itching has since subsided. On 04-DEC-2013, two days after getting the shot the patient recovered from the events. The patient did not received treatment for the adverse events. The patient did not seek medical attention. No diagnostics studies were performed. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: The day after vaccine administered, patient came to clinic complaining of soreness, redness, warm to touch area around injection site. Patient's temperature was 98.2. Redness started last night.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient recieved a Tdap vaccine on 11/19/13 and a second Tdap vaccine was administered on 12/18/13.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Electrocardiogram, Supraventricular tachycardia, Vision blurred
Clinical narrative: Extreme dizziness, SVT's and blurred vision.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Eye irritation, Increased upper airway secretion, Oropharyngeal pain
Clinical narrative: Upper respiratory reaction with drainage, sore throat, and eye irritation.  By 8:00pm spiked temp of 101 and chills.  The next day minor sore throat but everything else resolved.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Respiratory disorder
Clinical narrative: Upper respiratory reaction with drainage, sore throat, and eye irritation.  By 8:00pm spiked temp of 101 and chills.  The next day minor sore throat but everything else resolved.
Age: 33.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Pt states that he noticed extreme soreness and redness in arm 2 days post injection, pt denies itching, took ibuprofen OTC and was prescribed Cetirizine 10mg to take one daily for 5 days by provider.
Age: 4.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Chest X-ray abnormal, Hypoxia, Influenza, Influenza A virus test positive, Pneumonia
Clinical narrative: Pt presented to ER with croup like sx.  Presented to private office 1/3/14 with pneumonia, hypoxemia, positive for Influenza A.  Admitted to hospital for treatment.
Age: 4.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Pseudocroup
Clinical narrative: Pt presented to ER with croup like sx.  Presented to private office 1/3/14 with pneumonia, hypoxemia, positive for Influenza A.  Admitted to hospital for treatment.
Age: 4.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Blood test normal, Body temperature increased, Cough, Dyspnoea, Hypoxia
Clinical narrative: Pt presented to ER with croup like sx.  Presented to private office 1/3/14 with pneumonia, hypoxemia, positive for Influenza A.  Admitted to hospital for treatment.
Age: 4.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Influenza, Influenza A virus test positive, Influenza virus test positive, Malaise, Pneumonia
Clinical narrative: Pt presented to ER with croup like sx.  Presented to private office 1/3/14 with pneumonia, hypoxemia, positive for Influenza A.  Admitted to hospital for treatment.
Age: 4.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Vomiting
Clinical narrative: Pt presented to ER with croup like sx.  Presented to private office 1/3/14 with pneumonia, hypoxemia, positive for Influenza A.  Admitted to hospital for treatment.
Age: 24.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Drug administered at inappropriate site, Injection site pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: I received the flu injection much higher than a IM injection should be, it was painful upon administration. Within 2 hours of the injection, my entire arm was in severe pain and I had very limited range of motion and weakness. For the next 3 days I took over-the-counter Motrin so that the pain would subside enough for me to somewhat use my arm. After 3 days, 12/21/13, the pain was not as severe. One week later on 12/26/13, I was still having moderate pain, moderate decrease in range of motion and some weakness. I went to an Urgent Care and they prescribed my Naproxen, antiinflammatory, and suggested I get an MRI to see what kind of damage/inflammation was done. Today 1/3/13, 2 weeks later, I am still having moderate pain, decreased range of motion, and some weakness. The prescribed Naproxen is not helping. I have not received the MRI due to financial reasons.
Age: 24.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: I received the flu injection much higher than a IM injection should be, it was painful upon administration. Within 2 hours of the injection, my entire arm was in severe pain and I had very limited range of motion and weakness. For the next 3 days I took over-the-counter Motrin so that the pain would subside enough for me to somewhat use my arm. After 3 days, 12/21/13, the pain was not as severe. One week later on 12/26/13, I was still having moderate pain, moderate decrease in range of motion and some weakness. I went to an Urgent Care and they prescribed my Naproxen, antiinflammatory, and suggested I get an MRI to see what kind of damage/inflammation was done. Today 1/3/13, 2 weeks later, I am still having moderate pain, decreased range of motion, and some weakness. The prescribed Naproxen is not helping. I have not received the MRI due to financial reasons.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Decreased appetite, Fatigue, Irritability, Somnolence, Strabismus
Clinical narrative: Displayed excessive sleepiness and would not eat from 1-5:15pm, even though his prior feeding had been at 10AM.  Tried to wake him to feed, extremely fussy and seemed tired.  Slept until around 5:30pm.  Was very fussy, to the point that we had to give him Tylenol at 6:00pm, and were then able to feed him at 7:00pm.  Seemed overall more disinterested in things that otherwise had entertained him.  Crossing of eyes in the car ride home at 12:30pm, also later that evening.  The next day he was not as sleepy, though more so than previously; returned to a relatively normal cycle following this period.
Age: 5.0
Sex: M
Vaccine: DTAP, FLUN4, IPV, MMRV, FLUN4
Symptoms: Croup infectious, Influenza A virus test positive, Lymphadenopathy, Pyrexia
Clinical narrative: Pt had been seen 12/18/13 at doctor with 48 hours of fever and croup like sx. Later that evening/early the next am, he developed acute submandibular lymphadenopathy that prompted his parents to take him to the ER.  He tested positive for Influenza A at that time.  The lab typed it as H1N1.
Age: 5.0
Sex: M
Vaccine: DTAP, FLUN4, IPV, MMRV, FLUN4
Symptoms: Cough, Croup infectious, Influenza, Influenza A virus test positive, Pyrexia
Clinical narrative: Pt had been seen 12/18/13 at doctor with 48 hours of fever and croup like sx. Later that evening/early the next am, he developed acute submandibular lymphadenopathy that prompted his parents to take him to the ER.  He tested positive for Influenza A at that time.  The lab typed it as H1N1.
Age: 5.0
Sex: M
Vaccine: DTAP, FLUN4, IPV, MMRV, FLUN4
Symptoms: Salivary gland enlargement
Clinical narrative: Pt had been seen 12/18/13 at doctor with 48 hours of fever and croup like sx. Later that evening/early the next am, he developed acute submandibular lymphadenopathy that prompted his parents to take him to the ER.  He tested positive for Influenza A at that time.  The lab typed it as H1N1.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Client fainted after injection given and bandaid was applied to injection site. No injury.  Supportive treatment until awoke from faint.
Age: 0.33
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Pt.'s parents returned to Immunization clinc @ approximately 13:30. Pt had local reaction the Right thigh was red, swollen and warm and painful to touch.
Age: 13.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Dizziness, Fall
Clinical narrative: Patient was leaving clinic and felt faint, slid down but did not fall on floor, her mother caught her. Was conscious the whole time, no sign of seizure activity. Possible vaso vagal response.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Headache, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: Immediate sharp, burning, aching pain during administration of vaccine in left upper arm via needle. Within hours, severe arm pain requiring use of sling. Could not lift or use arm without severe pain for approximately 6 weeks. The same evening of the vaccine, additional pain and stiffness started in left shoulder, across upper back and into neck, resulting in daily headaches that are still occurring, waking me up frequently during sleep and most severe in the mornings upon waking. The site of the vaccination is still sore and very sensitive to pressure.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Middle insomnia, Neck pain, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: Immediate sharp, burning, aching pain during administration of vaccine in left upper arm via needle. Within hours, severe arm pain requiring use of sling. Could not lift or use arm without severe pain for approximately 6 weeks. The same evening of the vaccine, additional pain and stiffness started in left shoulder, across upper back and into neck, resulting in daily headaches that are still occurring, waking me up frequently during sleep and most severe in the mornings upon waking. The site of the vaccination is still sore and very sensitive to pressure.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Heart rate increased, Nausea, Palpitations
Clinical narrative: Nausea, headache, chills, rapid heart beat, palpatations.
Age: 0.23
Sex: M
Vaccine: PNC13
Symptoms: Asterixis, Erythema, Gaze palsy, Headache, Injury
Clinical narrative: Eyes rolling! Hand flapping! Screaming for hours! Redness!  Rocking back and forth! Touching head continuously. Vaccine injury!!!!!!!!!!!!!!!!!!!
Age: 0.23
Sex: M
Vaccine: PNC13
Symptoms: Movement disorder, Screaming
Clinical narrative: Eyes rolling! Hand flapping! Screaming for hours! Redness!  Rocking back and forth! Touching head continuously. Vaccine injury!!!!!!!!!!!!!!!!!!!
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Redness, warm, tender at injection site (L deltoid). Redness measures 60mm x40mm.  Firm area measures 50mm x30mm.  Itching anterior upper arm.  States she is not feeling well and is very fatigued.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Malaise
Clinical narrative: Redness, warm, tender at injection site (L deltoid). Redness measures 60mm x40mm.  Firm area measures 50mm x30mm.  Itching anterior upper arm.  States she is not feeling well and is very fatigued.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pt described that the injection site was red, swollen, painful, and itching the night of receiving the vaccine. Pt came to pharmacy 3 days later and the injection site was still present and was approximately 2 inches in diameter.
Age: 34.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Herpes zoster, Pain, Pruritus, Skin disorder
Clinical narrative: Head acheItchy bite marks on mid chest and under left armpit.  Severe pain on left side of torso.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Swelling face
Clinical narrative: Patient described swelling of hands, feet, and face. Also skin color was red. She took an antihistamine pill. The RPh on duty told her to go to the urgent care.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia areata, Laboratory test abnormal
Clinical narrative: Alopecia areata of note at base of skull and left temporal area since 6/20/13, labs WNL, dermatologist involved in care.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Influenza like illness, Malaise, Pain
Clinical narrative: Vaccine administered at 0900 on 01/02/14. Reports started to feel ill at 1300. "I was very, very, ill last evening, I threw up, had a fever of 100.5, diarrhea, aches and pains and chills. I felt like I had the flu. I was fine by midnight. Same thing happened last time I got it too".
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vaccine administered at 0900 on 01/02/14. Reports started to feel ill at 1300. "I was very, very, ill last evening, I threw up, had a fever of 100.5, diarrhea, aches and pains and chills. I felt like I had the flu. I was fine by midnight. Same thing happened last time I got it too".
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Cellulitis (redness and warmth) extending down arm from injection site.
Age: 7.0
Sex: F
Vaccine: DTAP, FLUN4, HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: DTaP inj. 12/16/13. Father calling to relay concern for adverse reaction 12/19/13 L-thigh inj site 6" diameter red, warm to touch and itchy.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Skin reaction
Clinical narrative: Local cutaneous reaction. (Redness swelling at injection site). Resolved 3-4 days after injection (pt used cold compress and massage).
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information was received from a health professional regarding a patient, demographics unknown, who on an unknown date, was vaccinated with VARIVAX (Merck) lot #J003221, expiration date 15-MAR-2015, which had been improperly stored. The outcome of the improperly stored vaccination was unknown. This is a corrected report. On 23-SEP-2013, information was received from a registered nurse concerning the unknown age and gender patient. It was reported that VARIVAX (Merck) was exposed to unknown temperatures for 5 hours during interoffice transport. The patient was revaccinated. No adverse symptoms reported. This is one of several reports from the same source. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Blood cholesterol increased, Blood glucose normal, Exposure during pregnancy, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician, refers to a 19 year old female patient without pertinent medical history or drug reactions/allergies. On 13-NOV-2013, the patient was vaccinated with a first dose of GARDASIL, 0.5 ml, intramuscular, lot # H017698; Expiration date 02-JUL-2015. No concomitant medications were reported. The patient became pregnant with Last Menstrual Period (LMP) of 15-APR-2013. On 16-DEC-2013, the physician was informed that the patient was pregnant. The method to use to confirm pregnancy was unspecified. Estimated Delivery Date (EDD) of 20-JAN-2014. Gestation "about 35 weeks". The foetus exposition was during the third trimester. The pregnancy outcome was unknown. On 16-DEC-2013, the physician was informed that the patient was pregnant. The method use to confirm pregnancy was unspecified. No treatment was given for the event. On an unknown date, the lab diagnostics studies performed: Glucose - normal, Cholesterol - 213, Liver enzymes - normal, Hemoglobin: 9.5, Hematocrit: 29.0. The patient did not seek medical attention. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Liver function test normal, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician, refers to a 19 year old female patient without pertinent medical history or drug reactions/allergies. On 13-NOV-2013, the patient was vaccinated with a first dose of GARDASIL, 0.5 ml, intramuscular, lot # H017698; Expiration date 02-JUL-2015. No concomitant medications were reported. The patient became pregnant with Last Menstrual Period (LMP) of 15-APR-2013. On 16-DEC-2013, the physician was informed that the patient was pregnant. The method to use to confirm pregnancy was unspecified. Estimated Delivery Date (EDD) of 20-JAN-2014. Gestation "about 35 weeks". The foetus exposition was during the third trimester. The pregnancy outcome was unknown. On 16-DEC-2013, the physician was informed that the patient was pregnant. The method use to confirm pregnancy was unspecified. No treatment was given for the event. On an unknown date, the lab diagnostics studies performed: Glucose - normal, Cholesterol - 213, Liver enzymes - normal, Hemoglobin: 9.5, Hematocrit: 29.0. The patient did not seek medical attention. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Condition aggravated, Psoriasis, Rash morbilliform
Clinical narrative: This spontaneous report as received from a 71 year old female consumer reporting on herself with 5 years of psoriasis around ears, diabetes, high blood pressure and no drug reactions or allergies who on an unspecified date in September 2013 was vaccinated with ZOSTAVAZX (dose, route and lot # not provided). Concomitant therapies included FLUZONE. On an unspecified date, a day or two later in September 2013, patient stated her psoriasis started coming out all over her body described as she broke out like in measles on her stomach, under her breasts, arms, legs, back and in hair. Patient sought medical attention at physician's office on an unspecified date and was treated with an unspecified spray, topical triamcinolone, methotrexate, folic acid and twelve laser treatments since an unspecified date. A blood work was performed which was okay.The outcome of patient psoriasis started coming out all over her body described as she broke out like,e in measles on her stomach, under her breasts, arms, legs, back and in hair was reporting as recovering. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: Patient said arm was extremely sore; later in the evening on the day she received vaccine her arm became very red at injection site and extremely painful to touch. Patient claims she could not lift her arm at all. Saw MD on 12/27/13 for pain and received numbing cream and pain killers.
Age: 11.0
Sex: F
Vaccine: HPVX
Symptoms: Skin papilloma
Clinical narrative: She now has a wart on her thumb and I just saw another one between her fingers.  I'm not sure if the vaccine was the cause or if its just a coincidence....I've taken her to the Dr and they are now checking to see if the insurance will cover freezing it.
Age: 65.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lymph node pain, Lymphadenopathy
Clinical narrative: Injection site started swelling and was very sore to touch; lymph glands are sore and swollen also. Now injection site is very red and swollen.
Age: 62.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Dysphonia, Dyspnoea, Hypersensitivity, Lacrimation increased, Pruritus
Clinical narrative: Received shingles vaccine. Within 5 minutes there was throat closure, hoarseness, itchy/watery eyes, and shortness of breath. Was immediately given a shot of Benadryl, taken to ER and given prednisone and additional Benadryl.
Age: 62.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Throat tightness
Clinical narrative: Received shingles vaccine. Within 5 minutes there was throat closure, hoarseness, itchy/watery eyes, and shortness of breath. Was immediately given a shot of Benadryl, taken to ER and given prednisone and additional Benadryl.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Serious hives over 25% of body lasting for 6 days, took Benadryl every day and they went away but came back in 24 hrs. I have never had hives before.
Age: 61.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Discomfort, Drug administered at inappropriate site, Injection site discomfort
Clinical narrative: Shot was administered into tendon and joint causing continued discomfort that has not gone away. After a year of discomfort, therapy was started for 3 months and is ongoing at home with minimal improvement. The discomfort feels like I got the shot yesterday, even though it was over 2 yrs. ago. The discomfort caused me to skip a year of protection from the flu. And changed my immunization site to my rear.
Age: 0.15
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Hyporesponsive to stimuli, Irritability, Screaming, Staring
Clinical narrative: Screaming for >3hrs.  Inconsolable.  Staring & poorly responsive.  By the next morning patient back to herself.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Headache
Clinical narrative: severe chills, dizziness, headache
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Movement disorder, Myalgia, Pain
Clinical narrative: Deep muscle ache on arm where tetanus vaccination administered.  Could barely move arm for 1 week.  Constant throbbing and aching even after 2 weeks.  Still having sharp pain on arm muscle when rotating arm upwards.  Went to Urgent Care on 1/4/2013 -- referred me to orthopedist to evaluate muscle damage.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Musculoskeletal pain, Pain in extremity, Radiculitis brachial, Vaccination complication
Clinical narrative: Deep muscle ache on arm where tetanus vaccination administered.  Could barely move arm for 1 week.  Constant throbbing and aching even after 2 weeks.  Still having sharp pain on arm muscle when rotating arm upwards.  Went to Urgent Care on 1/4/2013 -- referred me to orthopedist to evaluate muscle damage.
Age: 24.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Neck pain, Pain in extremity, Pyrexia, Urticaria
Clinical narrative: Fever of 104, immense excruciating neck pain, arm has welt on it, and is in large amount of pain.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Blood pressure increased, Dyspnoea, Eye swelling, Flushing
Clinical narrative: Anaphylactic reaction starting with flushed face, red eyes, eye swelling proceeding to skin rash, rapid heart rate, trouble breathing. Went to ER and was administered steroids and antihistamine and prescribed same. Reaction continued and had to take 2nd course of steroids.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased, Ocular hyperaemia, Rash
Clinical narrative: Anaphylactic reaction starting with flushed face, red eyes, eye swelling proceeding to skin rash, rapid heart rate, trouble breathing. Went to ER and was administered steroids and antihistamine and prescribed same. Reaction continued and had to take 2nd course of steroids.
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Dizziness, Headache, Malaise, Pain
Clinical narrative: FEVER (high of 102) x 3 DAYS, GENERALIZED MAILSE, BODY ACHES, CHILLS, HEADACHE, DIZZINESS FOR 4 DAYS
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: FEVER (high of 102) x 3 DAYS, GENERALIZED MAILSE, BODY ACHES, CHILLS, HEADACHE, DIZZINESS FOR 4 DAYS
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Injection site induration, Injection site swelling, Injection site warmth, Tenderness
Clinical narrative: Hard, hot, raised area approx. 1 cm below injection site.  Approx. 5 cm wide by 3 cm--elliptical in shape.  The erythema was very tender to light touch.
Age: 11.0
Sex: M
Vaccine: HPVX, MNQ, TDAP
Symptoms: Injection site atrophy, Injection site erythema, Injection site swelling, Oedema peripheral
Clinical narrative: He had the Tdap and meningococcal in his LA and HPV in his RA. His right arm did fine. By evening, his left bicep was swollen and red around the injection site. By the next morning, it was even larger and he had fluid building under his armpit. It continued to worsen throughout the day and by the evening the red portion covered all of his bicep and below and the swelling underneath the arm felt like a fluid filled balloon and almost made his armpit indistinguishable. I finally called our family physician on his cell that evening (he is a friend) and told him what was going on.  I was already icing it regularly and giving him ibuprofen.  He said that was really all I could do. I asked him if I should let the Health Department know the next day and he said that I could, but that they probably wouldn't do anything about it. My concern was for the next time he has to have this vaccine (in 10 years) - I wanted the reaction documented because I won't be with him when he receives it as an adult.  On 1/2/14, I took him to the HD and let someone look at it - the injection site also looked sunken by then (similar to old small-pox types spots).  She said this is "normal" and "occurs 50% of the time" with Tdap and that it is often bad in teens and adults.  I knew this wasn't entirely true, because his 2 older brothers didn't have this reaction.  Also, the hand-out did not have underarm swelling as an adverse effect or any reaction being 50% likely. She dismissed it as no big deal, but did say that his reaction was maybe a little worse than most.  I will never allow 2 injections to be given in the same extremity again.  Also, if this is common, someone should tell the parent to expect this reaction and definitely start icing and ibuprofen ahead of time.  Either he had an atypical reaction and someone should have documented it - neither Dr. or other person at the Health Department made any notes of his reaction - or the paperwork needs to be redone to make a parent aware that this is normal and they should go ahead and start icing and ibuprofen as soon as they get home.  I do have pictures of what his arm looked like on 1/1/13.  Today (1/4/13) the swelling has gone down a lot, but it isn't entirely gone. After looking at the next page, just to be clear: Left arm: Tdap & Meningoccal Right arm:  HPV (I have no way of knowing the manufacturers since they didn't even take my concern seriously.  I just picked a manufacturer on the one and picked something so it would let me submit.  You should really correct this issue as a parent has no way of knowing this information.)
Age: 31.0
Sex: M
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Electromyogram, Guillain-Barre syndrome, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Confirmed Guillain Barre Syndrome.
Age: 31.0
Sex: M
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Guillain-Barre syndrome, Headache, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Confirmed Guillain Barre Syndrome.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Swelling face
Clinical narrative: Patient had a swollen face and a severe headache.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Bacterial infection, Eye infection viral
Clinical narrative: Patient says day after receiving ZOSTAVAX that she developed a viral infection in her eye, no rash. Then she got a bacterial infection. She was in the hospital 2 days on IV antibiotics.
Age: 0.71
Sex: M
Vaccine: FLUX, HEPA, VARCEL
Symptoms: Abnormal behaviour, Lethargy, Pyrexia, Tremor
Clinical narrative: Started with high fever 104.7 then my son started acting differently. He then became lethargic and shook a little I then rushed him to the ER
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Aphonia, Cough, Fatigue, Muscular weakness, Paraesthesia
Clinical narrative: Started having cough, sinus drip, and lost my voice completely, started having tingling in chest area with cough, fatigue, leg weakness, by Jan 2, was having serious cough, and called doctor.  Symptoms stopped by Jan 4 with exception of voice.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Upper-airway cough syndrome
Clinical narrative: Started having cough, sinus drip, and lost my voice completely, started having tingling in chest area with cough, fatigue, leg weakness, by Jan 2, was having serious cough, and called doctor.  Symptoms stopped by Jan 4 with exception of voice.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Abdominal pain upper, Menstrual disorder, Oligomenorrhoea
Clinical narrative: Some severe pains in her stomach every so often but from there she had an abnormal menstrual cycle where she had bleed for 6 months straight and had to take birth control pills (which can cause cancer in her ovaries in her future) for two and a half years.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Swelling
Clinical narrative: Arm pain after vaccine administration that has persisted to present time.  Patient administered ibuprofen and ice to reduce swelling, which relieved pain, but pain resumed when IBU and ice were withdrawn.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Nipple pain
Clinical narrative: Severe pain behind nipple of left breast.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure increased, Chest discomfort, Dizziness, Injection site pruritus, Injection site rash
Clinical narrative: Patient felt dizzy and had itching and rash at injection site that appeared to be getting larger.  Chest felt tight and blood pressure was elevated.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site swelling
Clinical narrative: PATIENT COMPLAINED OF SWELLING AT SITE OF THE INJECTION AND SEVERE HEADACHE.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site induration, Injection site nodule, Injection site rash
Clinical narrative: Hard knot at injection site followed by approx. 4" diameter rash that started to wrap around arm. Pt started on cephalexin 500mg QID x 10 days. Pt was given an intradermal flu shot. Injection site was prepped with alcohol pad prior to admin. Needle cover was removed immediately prior to administration.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site infection, Injection site reaction
Clinical narrative: Hard knot at injection site followed by approx. 4" diameter rash that started to wrap around arm. Pt started on cephalexin 500mg QID x 10 days. Pt was given an intradermal flu shot. Injection site was prepped with alcohol pad prior to admin. Needle cover was removed immediately prior to administration.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: Received flu shot 12/31/13. 1/1/14 injection site okay but large bright red area below site. By 1/2/14, area red, bruised and reaching downward toward elbow.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with haemophilus b conjugate (manufacturer unknown) (dose and route unknown)(lot# H021195, exp date 21-SEP-2015). It was reported that the vaccine was improperly stored and was exposed to unknown temperature for 4 hours during interoffice transport. All vaccines were unsupported and were possibly administered to patients. No adverse symptoms reported. Nurse was unable to provide further temperature excursion details, dates of administration. All the patients had been revaccinated. No symptoms reported. This was the only information she could provide. This is one of several reports that received from the same source. The case is linked to 1311USA000056, 1310USA014891, 1310USA014881, 1310USA014883, 1310USA014888, 1310USA015417, 1311USA000071, 1311USA000012, 1310USA015858, 1310USA014850, 1310USA014870, 1311USA000289, 1311USA000282, 1310USA014874, 1310USA014861, 1310USA014866, 1310USA014868, 1310USA015422, 1310USA015165, 1311USA000069, 1310USA015424, 1311USA000058, 1311USA000042, 1311USA000013, 1310USA015170, 1311USA000014, 1310USA015153, 1310USA015090, 1311USA000067, 1311USA000064, 1311USA000021, 1311USA000020, 1311USA000022, 1310USA015101, 1310USA014853, 1311USA000075, 1310USA014895, 1310USA015119, 1310USA015113, 1311USA000059, 1311USA004931, 1311USA000065, 1311USA000739, 1311USA000040, 1310USA015096, 1311USA000642, 1310USA014958, 1311USA000072, 1310USA015127, 1311USA000053, 1311USA000085, 1311USA000741, 1311USA000744, 1310USA015134, 1311USA000083, 1310USA015141, 1311USA000006, 1311USA000005, 1310USA014900, 1310USA015268, 1310USA015264, 1310USA014896, 1310USA014909, 1311USA000627, 1310USA015396, 1310USA015270, 1311USA000637, 1310USA014962, 1311USA000039, 1311USA000037, 1311USA000034, 1311USA000032, 1311USA000002, 1310USA014897 and 1309USA011086. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information was received from an unspecified health professional regarding a patient (demographics unknown), who on unknown date, was vaccinated with VARIVAX (Merck) lot # J003221, expiration date 15-MAR-2015, which had been improperly stored. The outcome of the improperly stored vaccination was unknown. Follow up information has been received from a nurse who called and stated all patients (who received VARIVAX (Merck) that was exposed to unknown temperatures for 4 hours) had been revaccinated. No symptoms reported. This is one of several reports received from the same source (linked MARRS#:1311USA000056, 1310USA014891, 1310USA014881, 1310USA014883, 1310USA014888, 1310USA015417, 1311USA000071, 1311USA000012, 1310USA014858, 1310USA014850, 1310USA014870, 1311USA000289, 1311USA000282, 1310USA014874, 1310USA014861, 1310USA014866, 1310USA014868, 1310USA015422, 1311USA000069, 1310USA015424, 1311USA000058, 1311USA000042, 1310USA015170, 1311USA000014, 1310USA015153, 1310USA015090, 1311USA000067, 1311USA000064, 1311USA000021, 1311USA000020, 1311USA000022, 1310USA015101, 1310USA014853, 1311USA000075, 1310USA014895, 1310USA015119, 1310USA015113, 1311USA000059, 1311USA004931, 1311USA000065, 1311USA000739, 1311USA000040, 1310USA015096, 1311USA000642, 1310USA014958, 1311USA000072, 1310USA015127, 1311USA000053, 1311USA000085, 1311USA000741, 1311USA000744, 1310USA015134, 1311USA000083, 1310USA015141, 1311USA000006, 1311USA000005, 1310USA014900, 1310USA015268, 1310USA015264, 1310USA014896, 1310USA014909, 1311USA000627, 1310USA015396, 1310USA015270, 1311USA000637, 1310USA014962, 1311USA000039, 1311USA000037, 1311USA000032, 1311USA000002, 1310USA014897, 1309USA011086). Additional information is not expected.
Age: 23.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Rash started on neck; itchy, red; still has it 6 weeks later.
Age: 1.8
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Localized erythema and tenderness at injection site. Treatment with warm compresses; will start BACTRIM if increases in size.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified patients of unknown demographics. On an unknown date the patient was vaccinated with PNEUMOVAX23 lot # J010654, expiry date: 17-OCT-2014 (dosing regimen unspecified). No concomitant medications were reported. On an unknown date medication error was reported as the nurse stated that PNEUMOVAX23, lot J010654 expiry date: 17-OCT-2014 as well as other unspecified PNEUNOVAX23 lot numbers was exposed to between 17F (Fahrenheit) and 24 F since January 2013 (365 days). The improperly stored PNEUMOVAX23 was administered to an unspecified number of unspecified patients on unspecified dates. No adverse effect reported. There was no product quality complaint (PQC) involved. Outcome was unknown. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Erythema, Influenza like illness, Lethargy, Pyrexia
Clinical narrative: Information has been received from a 62 year old female registered nurse who is the patient. The patient's medical history included in 2012 right arm and leg were paralyzed, and right arm and right leg could not move them by herself and right arm and right leg were numb, right arm and right left felt they were asleep after vaccinated with PENUMOVAX23 (MARRS#1312USA011693). On 25-NOV-2013 the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, subcutaneous in the left arm, lot # J007301, expiration date 20-SEP-2014). Concomitantly, the patient annually has been administered with FLUVIRON (manufacturer unknown) since 1993 (dose, route, and lot number were not provided). On 18-OCT-2013 or 19-OCT-2013, the patient received her most recent dose of FLUVIRON. On 25-NOV-2013, she was vaccinated with ZOSTAVAX and reported developing "flu like symptoms" on 05-DEC-2013 described as a fever ranging from 101 Fahrenheit to "almost 103" Fahrenheit, chills, lethargy and confinement to bed from 05-DEC-2013 to 07-DEC-2013. "Flu like symptoms" resolved completely on 10-DEC-2013. Nurse additionally reported that on 13-DEC-2013 she developed a rash which began on the left side of her chest and described as pimples which progressed to "V" of chest and then to right side of neck and a cross the median line. The pimples were itchy and red. Nurse stated that she thought the rash may have been chickenpox. Treatment for the rash was over the counter 1% hydrocortisone cream. The rash was resolving and described as most are dried up with some areas that are still itchy and red. Laboratory test was not performed. The patient did not seek medical attention. At the time of the report, the patient was recovering. This is one of several reports from the same patient. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash pruritic, Varicella
Clinical narrative: Information has been received from a 62 year old female registered nurse who is the patient. The patient's medical history included in 2012 right arm and leg were paralyzed, and right arm and right leg could not move them by herself and right arm and right leg were numb, right arm and right left felt they were asleep after vaccinated with PENUMOVAX23 (MARRS#1312USA011693). On 25-NOV-2013 the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, subcutaneous in the left arm, lot # J007301, expiration date 20-SEP-2014). Concomitantly, the patient annually has been administered with FLUVIRON (manufacturer unknown) since 1993 (dose, route, and lot number were not provided). On 18-OCT-2013 or 19-OCT-2013, the patient received her most recent dose of FLUVIRON. On 25-NOV-2013, she was vaccinated with ZOSTAVAX and reported developing "flu like symptoms" on 05-DEC-2013 described as a fever ranging from 101 Fahrenheit to "almost 103" Fahrenheit, chills, lethargy and confinement to bed from 05-DEC-2013 to 07-DEC-2013. "Flu like symptoms" resolved completely on 10-DEC-2013. Nurse additionally reported that on 13-DEC-2013 she developed a rash which began on the left side of her chest and described as pimples which progressed to "V" of chest and then to right side of neck and a cross the median line. The pimples were itchy and red. Nurse stated that she thought the rash may have been chickenpox. Treatment for the rash was over the counter 1% hydrocortisone cream. The rash was resolving and described as most are dried up with some areas that are still itchy and red. Laboratory test was not performed. The patient did not seek medical attention. At the time of the report, the patient was recovering. This is one of several reports from the same patient. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Influenza, Lethargy, Malaise, Pyrexia
Clinical narrative: Information has been received from a 62 year old female registered nurse who is the patient. The patient's medical history included in 2012 right arm and leg were paralyzed, and right arm and right leg could not move them by herself and right arm and right leg were numb, right arm and right left felt they were asleep after vaccinated with PENUMOVAX23 (MARRS#1312USA011693). On 25-NOV-2013 the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, subcutaneous in the left arm, lot # J007301, expiration date 20-SEP-2014). Concomitantly, the patient annually has been administered with FLUVIRON (manufacturer unknown) since 1993 (dose, route, and lot number were not provided). On 18-OCT-2013 or 19-OCT-2013, the patient received her most recent dose of FLUVIRON. On 25-NOV-2013, she was vaccinated with ZOSTAVAX and reported developing "flu like symptoms" on 05-DEC-2013 described as a fever ranging from 101 Fahrenheit to "almost 103" Fahrenheit, chills, lethargy and confinement to bed from 05-DEC-2013 to 07-DEC-2013. "Flu like symptoms" resolved completely on 10-DEC-2013. Nurse additionally reported that on 13-DEC-2013 she developed a rash which began on the left side of her chest and described as pimples which progressed to "V" of chest and then to right side of neck and a cross the median line. The pimples were itchy and red. Nurse stated that she thought the rash may have been chickenpox. Treatment for the rash was over the counter 1% hydrocortisone cream. The rash was resolving and described as most are dried up with some areas that are still itchy and red. Laboratory test was not performed. The patient did not seek medical attention. At the time of the report, the patient was recovering. This is one of several reports from the same patient. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Information has been received from a 62 year old female registered nurse who is the patient. The patient's medical history included in 2012 right arm and leg were paralyzed, and right arm and right leg could not move them by herself and right arm and right leg were numb, right arm and right left felt they were asleep after vaccinated with PENUMOVAX23 (MARRS#1312USA011693). On 25-NOV-2013 the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, subcutaneous in the left arm, lot # J007301, expiration date 20-SEP-2014). Concomitantly, the patient annually has been administered with FLUVIRON (manufacturer unknown) since 1993 (dose, route, and lot number were not provided). On 18-OCT-2013 or 19-OCT-2013, the patient received her most recent dose of FLUVIRON. On 25-NOV-2013, she was vaccinated with ZOSTAVAX and reported developing "flu like symptoms" on 05-DEC-2013 described as a fever ranging from 101 Fahrenheit to "almost 103" Fahrenheit, chills, lethargy and confinement to bed from 05-DEC-2013 to 07-DEC-2013. "Flu like symptoms" resolved completely on 10-DEC-2013. Nurse additionally reported that on 13-DEC-2013 she developed a rash which began on the left side of her chest and described as pimples which progressed to "V" of chest and then to right side of neck and a cross the median line. The pimples were itchy and red. Nurse stated that she thought the rash may have been chickenpox. Treatment for the rash was over the counter 1% hydrocortisone cream. The rash was resolving and described as most are dried up with some areas that are still itchy and red. Laboratory test was not performed. The patient did not seek medical attention. At the time of the report, the patient was recovering. This is one of several reports from the same patient. Additional information has been requested.
Age: 35.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist who is 35 year old male patient concerning himself. Patient had no medical history and previous drug reaction. On 19-MAY-2012 the patient was vaccinated wit VARIVAX (Merck) (dose number, dose unit, lot# and expiry date unknown), subcutaneous. No concomitant medications were reported. On 19-MAY-2012, the patient experienced a reaction of small red bump that increased in size to approximately 3/4 of an inch, and mild itching. It was reported that patient visited physician and no treatment was given for the events. No laboratory tests were performed. The outcome of reaction of small red bump that increased in size to approximately 3/4 of an inch and mild itching was unknown. No  further information was provided. Additional information is not expected.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as receive from a pharmacist via a company representative refers to a 70 year old male patient. The patient had received an influenza vaccine (unspecified) (reported as unknown flu vaccine) about 2 weeks before vaccination with ZOSTAVAX, on appropriately 29-OCT-2013. On 12-NOV-2013 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # unspecified). Concomitant therapies included low dose prednisone(manufacturer unspecified). On 04-DEC-2013, the patient developed shingles after vaccination with ZOSTAVAX. The outcome of shingles was unknown. Additional information has been requested.
Age: 0.9
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to an 11 month old male patient. On an unknown date in April 2013 the patient was vaccinated with ROTATEQ (lot number and expiry date unknown) (dosing regimen and frequency unknown) orally. On an unknown date approximately in 2013 the patient has missed his 3rd dose with ROTATEQ by 3 months. No adverse events were reported. The action taken with ROTATEQ. The relatedness of the events to the ROTATEQ was unknown. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 7.5 x 9 cm area of erythema and induration on the left anterior thigh with warmth to touch, no central fluctuance appreciated.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Medical assistant refers to an unknown number of patients of unknown age and gender. The reporter mentioned that an unknown number of patients have received VARIVAX (Merck) (lot number and expiry date not reported) (dosing regimen and frequency unknown) from January 2013 to 16-DEC-2013 that may had an unknown number of excursions with temperatures from 3 degrees C to 7 degrees C and each excursion being 64 hours. No adverse effects reported. No product quality issue was reported. Follow-up information has been received from a medical assistant (who called to report specific administration dates), concerning a patient of unknown age and gender. On 04-MAR-2013 the patient had received a dose of VARIVAX (Merck) (lot number # H011233, exp. date: 06-JUN-2014) (dosing regimen and frequency were not provided). This dose of VARIVAX (Merck) had an unknown number of excursions with temperatures from minus 3 Celsius degree to minus 7 Celsius degree and each excursions being 64 hours. No adverse experiences were reported. This is one of 9 reports from the same source (# 1312USA008561; #1312USA011525; #1312USA011520; #1312USA011521; #1312USA011522; #1312USA011523; #1312USA011524; #1312USA011526). Additional information has been requested.