chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Exposure during pregnancy, Foetal heart rate abnormal, Haemorrhage in pregnancy, Ultrasound antenatal screen abnormal
Clinical narrative: Recieved Fluvirin on 10/13/2014, on 10/23/2014 had a ultrasound and saw that my baby had a strong heartbeat at that time, on 10/28/4014 I started spotting and on 11/10/2014 I started to bleed heavily so I had another ultrasound that day and found that the babys heart was no longer beating 11/12/2014 I miscarried my little baby. I read the Fluvirin pamphlet the day after I recieved the flu shot and noticed that there has been no testing on pregnant women. Its not 100% known to be safe. After reading that I had a feeling that I would miscarry the baby so I did everything right on my behalf to try to counteract this horrible flu vaccine I got. I have a perfect little boy that I gave birth to almost 2 years ago and had no complications with him. I do feel that the reason this baby did not make it was because of the shot.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Malaise, Urticaria
Clinical narrative: Vaccine administered early afternoon. Patient reports start of not feeling well med evening time. She woke up in hives all over face, neck, trunk hands etc. Not breathing difficulties reported, did go to Clinic and get prednisone pack and steroid injection.
Age: 17.0
Sex: F
Vaccine: HPVX, MEN
Symptoms: Asthenia, Eye pain, Headache, Swelling face, Urticaria
Clinical narrative: Hives on face, swelling of face, pain around right eye, body weakness, headaches.
Sex: F
Vaccine: FLUX
Symptoms: Central nervous system lesion, Multiple sclerosis relapse, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Initial report received from a consumer, who is also the patient, on 06 November 2014. A female patient, with a history of multiple sclerosis, received an INFLUENZA VACCINE (manufacturer and lot number not reported) on an unspecified date in 2008 or 2009. Additional medical history included diabetes, a history of multiple falls with subsequent broken bones, urinary incontinence and frequency, "very thirsty", depression, and "almost constant" yeast infections. She was also wheelchair bound. Following vaccination with influenza vaccine in 2008 or 2009, the patient experienced an exacerbation of her multiple sclerosis and was hospitalized for 3 or 4 days. Concomitant medications included BETASERON, insulin, anti-depressant, and a recent course of antibiotics and topical treatment for a yeast infection. The patient also noted that she occasionally forgot to take her medications. A recent MRI (one month prior to the report) had shown a lesion on the neck or spine. Outcome was not reported. Documents held by sender: None.
Sex: M
Vaccine: FLUX
Symptoms: Asthma, Foetal exposure during pregnancy, Food allergy, Swelling, Urticaria
Clinical narrative: Initial report was received on 06 November 2014 from a consumer who is also the patient's parent. An infant had received via the transplacental route sometime in October 2010 an Influenza vaccine (manufacturer, lot number, mother's route and site of administration and a specific date not reported) and within 10 months after birth developed an egg allergy with symptoms of hives, swelling and vomiting. The patient also developed multiple food allergies and has asthma. The reporter stated there was no family history of food allergies or asthma. The reporter believed that her son's allergies and asthma are reactions to her having received the flu vaccine during her pregnancy. The reporter stated she later had another child, daughter, and did not have the flu vaccine during that pregnancy and her daughter has none of the allergies or asthma like her first son. The reporter declined to provide name and contact information for either her OB/GYN provider or her child's pediatrician. Outcome was unknown. Documents held by sender: none.
Sex: M
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Initial report was received on 06 November 2014 from a consumer who is also the patient's parent. An infant had received via the transplacental route sometime in October 2010 an Influenza vaccine (manufacturer, lot number, mother's route and site of administration and a specific date not reported) and within 10 months after birth developed an egg allergy with symptoms of hives, swelling and vomiting. The patient also developed multiple food allergies and has asthma. The reporter stated there was no family history of food allergies or asthma. The reporter believed that her son's allergies and asthma are reactions to her having received the flu vaccine during her pregnancy. The reporter stated she later had another child, daughter, and did not have the flu vaccine during that pregnancy and her daughter has none of the allergies or asthma like her first son. The reporter declined to provide name and contact information for either her OB/GYN provider or her child's pediatrician. Outcome was unknown. Documents held by sender: none.
Age: 42.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: INJECTION SITE REACTION, SWELLING, PAIN, ERYTHEMA.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Headache, Nausea
Clinical narrative: Headache, chills, rigors followed by days of GI distress with nausea, vomiting and diarrhea. Imodium for diarrhea and dietary management of GI upset.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Headache, chills, rigors followed by days of GI distress with nausea, vomiting and diarrhea. Imodium for diarrhea and dietary management of GI upset.
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Culture throat, Headache, Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever, nasal congestion, sore throat, headaches.  Headaches started 3 days after Flu Mist.
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Streptococcus test negative
Clinical narrative: Fever, nasal congestion, sore throat, headaches.  Headaches started 3 days after Flu Mist.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Hypogeusia, Mouth haemorrhage
Clinical narrative: Developed metallic taste in mouth, decreased sense of taste and petichiae all over oral mucosa and palate.
Age: 36.0
Sex: F
Vaccine: FLUC3
Symptoms: Cheilitis, Immune system disorder, Influenza like illness, Malaise, Oropharyngeal pain
Clinical narrative: Flu like symptoms (sore throat, body ache, indisposition) and sore break out in the lower lips* (reaction to low/weakened immune system). * first observed 4 hours after immunization.
Age: 36.0
Sex: F
Vaccine: FLUC3
Symptoms: Pain
Clinical narrative: Flu like symptoms (sore throat, body ache, indisposition) and sore break out in the lower lips* (reaction to low/weakened immune system). * first observed 4 hours after immunization.
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Musculoskeletal stiffness, Nerve stimulation test, Tenderness, Ultrasound scan
Clinical narrative: Stiffness, tenderness, loss of strength, weakness. Treatment was ultrasound and ibuprofen.
Age: 51.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Electromyogram abnormal, Guillain-Barre syndrome, Lumbar puncture
Clinical narrative: Guillain-Barre Syndrome.
Age: 51.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Balance disorder, Electromyogram, Guillain-Barre syndrome, Hypertension, Lumbar puncture
Clinical narrative: Guillain-Barre Syndrome.
Age: 51.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: Guillain-Barre Syndrome.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Headache, Local swelling, Skin warm
Clinical narrative: Came in Saturday 10/25/14 with headache and red/warm swollen arm. Pt sent to ER. Diagnosed with cellulitis and sent home with antibiotic.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: I have both knees replaced several years ago. 24 hrs. after I received the flu vaccine both of my knees seized up. Took 3 days to get back to normal. Extreme pain.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Electrocardiogram, Insomnia, Nuclear magnetic resonance imaging brain, Vertigo
Clinical narrative: Flu shot Nov 2012. Insomnia starting night of injection lasting approximately 14 months, severe vertigo lasting past 2 years, better but not gone. Costing 20,000$ medical bills and 100,000$ in pain.
Age: 47.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: 2"x2" redness at injection site, warm to touch, itching around site.
Sex: F
Vaccine: FLU3
Symptoms: Local swelling
Clinical narrative: Arm very swollen. Went to med facility.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Aura, Confusional state, Convulsion, Coordination abnormal
Clinical narrative: About 1 hr after getting vaccine seizures, aura's confusion, coordination, not losing consciousness. Treats self for seizures.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Malaise, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever two days after lasting 4-5 days with nausea, vomiting, diarrhea and sick behavior.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Like being punched in the arm several time (Right arm).
Age: 1.85
Sex: F
Vaccine: FLU3
Symptoms: Full blood count normal, Henoch-Schonlein purpura, Metabolic function test normal, Rash
Clinical narrative: Pt developed Henoch Schonlein Purpura on 10/3/14. Dx'd via classic rash. No other sequelae developed.
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Erythema, Injected limb mobility decreased, Local swelling, Pain in extremity
Clinical narrative: Case number PHEH2014US022228 is an initial spontaneous report from the consumer via Pharmacy received on 04 Nov 2014. This report refers to a female patient of an unknown age. She was vaccinated with FLUVIRIN (batch number: 1412401) at a dose of 0.5 ml in her right arm on an unknown date. On 24 Oct 2014, after vaccination she experienced right arm redness, swelling, pain and could not move her arm. She was diagnosed with cellulitis and was given medication (unspecified). The final outcome, seriousness and causality of the events were not reported. Seriousness assessment of (cellulitis and injected limb mobility decreased) was upgraded based on the NVx key event list.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Immunodeficiency, Myalgia, Pain, Pyrexia
Clinical narrative: Case number PHEH2014US022105 is an initial spontaneous report received from a consumer (patient's wife) on 03 Nov 2014. This report refers to a 33 year old male patient. His past medical history and concomitant medications were not reported. On 22 Oct 2014, he was vaccinated with FLUVIRIN (batch number: 1412601) intramuscularly. The patient developed muscle aches, pains, fever and inability to open pill bottles or cut a steak since the vaccination. The patient was immunocompromised and would visit a neurologist. The outcome of the events was not reported. The seriousness of the events was not reported but events were upgraded based on the information available in the source documents. The causality of the events was not reported.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Sore arm, not getting better. Improves with ALEVE but not completely.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Pt has pain in left arm and shoulder. Feels like arm is coming out of socket. Pt been taking Naprosyn OTC since 10-15-14. We call Dr to see if the dr. would prescribe a stronger NSAID for him. The Dr. said the pt. would need to be seen. .... on 11-11-14 the pt's representative (spouse (female voice) called and said patient never made it in for the MRI. She was following up on the NSAID. I called and left a message on their answering service on 11-5-14 about what the Dr. said.... needed to be seen. When I spoke with the pt. on 11-3-14. He said that because he was a tall person, so he hunched over to try to make it easier for me to give him the vaccine.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Patient received Flu shot 9am and became very itchy hours later. A rash appeared on arm and neck on side where she got the shot. After taking BENADRYL 50 mg at 12 pm she was brought to the ER in town to get further care. Fine the next day.
Age: 1.46
Sex: M
Vaccine: FLUX, PNC, VARCEL
Symptoms: Dermatitis diaper, Diarrhoea, Insomnia, Irritability, Pyrexia
Clinical narrative: Diarrhea 9PM on 11/9/2014 through 12PM on 11/12/2014. Fever on 11/9/2014 off and on through 11/11/2014. Severe diaper rash from diarrhea 11/10/14 - 11/13/14 (continuing). Chicken pox rash (5 pox lesions), first one appearing on 11/10/14, the rest appearing Nov 11-12, 2014. Generalized sleeping difficulty, crankiness, etc.
Age: 1.46
Sex: M
Vaccine: FLUX, PNC, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Diarrhea 9PM on 11/9/2014 through 12PM on 11/12/2014. Fever on 11/9/2014 off and on through 11/11/2014. Severe diaper rash from diarrhea 11/10/14 - 11/13/14 (continuing). Chicken pox rash (5 pox lesions), first one appearing on 11/10/14, the rest appearing Nov 11-12, 2014. Generalized sleeping difficulty, crankiness, etc.
Age: 38.0
Sex: F
Vaccine: TYP
Symptoms: Cardiac failure, Eosinophilic myocarditis
Clinical narrative: These case reports were previously actioned by Crucell (BERNA-2009-0209). The data was taken directly from the database repository and entered verbatim (including labeling and causality assessments) on to the safety database. Where labeling and causality assessments were absent, took the decision to assign according to company guidelines. This case was received from Novartis Vaccine, no.: 199501487BW on 28.May.2002. A 38-year old female took Typhoral-L (Batch no.: unknown) due to planned travelling to the tropics. She was tentatively diagnosed with eosinophilic myocarditis 2 months after vaccination. Further data was requested. No further data was available. Seriousness: serious (hospitalization). Causality: insufficient information. This case was found during archiving activities and has not previously been entered into the global safety database. The case was processed using procedural documents and current labelling documents. The subject was diagnosed with suspicion of eosinophilic myocarditis/heart failure, 2 months after vaccination with typhoid vaccine oral ty21a. This case was serious (hospitalization).
Age: 1.71
Sex: F
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Rash, Rash erythematous
Clinical narrative: 10/7/14 - WCC with imm. given. Foster mother called 10/20/2014 stating patient developed a rash on 10/18, described as fine sm. red bumps on her torso and buttocks. Noted that area (R) lateral thigh where varicella immunization given 10/7 was bright red at this time.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Dyspnoea, Headache, Nausea, Pain
Clinical narrative: States had violent nausea and vomiting, high fever of 102-103, body and bone ache along with SOB. Then had headache from the 6th to the 9th. This was accompanied by hives and a rash over the entire body  which was worse under arms and breasts.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Rash generalised, Urticaria, Vomiting
Clinical narrative: States had violent nausea and vomiting, high fever of 102-103, body and bone ache along with SOB. Then had headache from the 6th to the 9th. This was accompanied by hives and a rash over the entire body  which was worse under arms and breasts.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: Patient received flu shot 10/06/14.  Patient presented back at pharmacy 11/13/14 with complaint of dull persistent pain in back of immunized arm.  According to patient account, vaccine suspected to be given by subcutaneous route in back of arm instead of deltoid muscle..
Age: 22.0
Sex: F
Vaccine: PPV, VARCEL
Symptoms: Feeling hot, Induration, Peripheral swelling
Clinical narrative: Swelling with firmness and warmth 4.5cm x 5.5cm to right arm.
Age: 30.0
Sex: M
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Injection site pain, Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: I noticed that I was extremely sore the day after receiving the flu shot, I could barely use my left arm.  As the week progressed the soreness started to taper off and seemed to be getting better until I woke up on November 10th finding my left arm to be extremely painful.  It is now November 13th and the pain is a 7 out of 10.  I am unable to use my left arm to assist in driving my car, lifting my purse, opening doors, and even getting dressed. The area around where the nurse delivered the shot is tender and my range of motion with my left arm is extremely limited. I can't get through the night and rest fully due to the pain that radiates in my arm.
Age: 47.0
Sex: F
Vaccine: HEPA
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt with complaints of tenderness at sight of injection and difficulty lifting arm (right) for 3 weeks. No treatment sought.
Age: 4.0
Sex: F
Vaccine: FLUN4
Symptoms: Computerised tomogram head normal, Convulsion, Full blood count normal, Metabolic function test normal, Postictal state
Clinical narrative: Seizure x's 1.  Was laying in bed and started having convulsions.  After the seizure she seemed to have a period that the mother describes as post-ictal.  She was brought to the local ER.  The attending physician felt it may have been related to having the Flu Mist administered earlier.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oral herpes
Clinical narrative: Beginning of cold sore to upper lip.
Age: 13.0
Sex: F
Vaccine: HEP, IPV, TD
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: On 10/22/14 PM client was brought to clinic by mom to consult regarding possible reaction to vaccine;  Nurse observed erythema area 4 cm x 5 cm on right upper arm, along with slightly warm and some swelling. Mom reported started 10/21/14 and Ct. stated accompanied by some itching. No treatment.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Malaise, Palpitations
Clinical narrative: Within 5 minutes of receiving the vaccine got lightheaded, malaise, blurred vision, heart palpitations, chest tightness, SOB/Assessed - monitored.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Vision blurred
Clinical narrative: Within 5 minutes of receiving the vaccine got lightheaded, malaise, blurred vision, heart palpitations, chest tightness, SOB/Assessed - monitored.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, C-reactive protein increased, Immediate post-injection reaction, Injection site pain, Leukocytosis
Clinical narrative: Immediate and persisting pain in (R) shoulder at FLUVAX site followed by diffuse severe polyarthralgia.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Red blood cell sedimentation rate increased
Clinical narrative: Immediate and persisting pain in (R) shoulder at FLUVAX site followed by diffuse severe polyarthralgia.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain
Clinical narrative: Back pain along the kidney area.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Left shoulder pain and limited movement from flu shot on 10/27/2014. States that the pain started an hour after the flu shot was given and slowly and progressively increased at the left deltoid and shoulder.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Blindness, Diplegia, Hypoaesthesia, Oral candidiasis, Paraesthesia
Clinical narrative: Thrush mouth, vision loss, tingling numb paralyzed legs.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Paraesthesia
Clinical narrative: Tingling hands and feet that wouldn't stop.  Continued for two weeks-got worse and turned to weakness.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient has rather severe pain in arm where vaccine was injected, patient cannot lay on said arm due to pain.  There is no knot or raised area.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Herpes zoster
Clinical narrative: I developed shingles 2 days after receiving a flu shot. It seems many others have too.
Age: 0.19
Sex: M
Vaccine: DTAP, HBHEPB, IPV, RVX
Symptoms: Rash, Respiratory syncytial virus test negative
Clinical narrative: Rash spreading over belly, moving to arms. No treatment given.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Local swelling, Neck mass, Oedema peripheral, Pain in extremity
Clinical narrative: Arm swelled and turned purple. Swelling radiated to neck. Large lump in neck. Swelling in armpit. Pain from elbow to head.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Skin discolouration
Clinical narrative: Arm swelled and turned purple. Swelling radiated to neck. Large lump in neck. Swelling in armpit. Pain from elbow to head.
Age: 9.0
Sex: F
Vaccine: FLUN4
Symptoms: Hallucination
Clinical narrative: Woke from sleep with hallucinations.  Was not making sense, but was aware that she was not making sense.  Mom called and I spoke to her.  Within half an hour, she had settled down and was able to fall back to sleep.  She seemed completely normal when she woke up the next morning.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Back pain, Pain
Clinical narrative: Within 24 hours, I developed intense, severe pain in my lower back. It was localized, but almost crippling. I was not able to get out of bed for the first day without great pain. As a result, I missed a day of work and had to take it as sick leave. It took a week for the pain to subside.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: At 7:15 patient started getting a headache took 2 Aleve and laid down for a nap. At 9pm she had a fever of 103.8 and the fever lasted an hour. She them had extreme headache. excurtiating pain like a charley horse in her legs and her hands and feet were tingling. There was no site reaction.
Age: 64.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Incorrect route of drug administration, Injected limb mobility decreased, Injection site pain, Insomnia, Tenderness
Clinical narrative: The next day I realized I had difficulty sleeping on my left side as my arm up near the injection site was quite sore. This has continued since that time. I have difficulty raising my arm, lifting anything with that arm and cannot put any pressure on it like sleeping. it is worse during the night. This is continuing since I was given the Fluarix Quadrivalent injection. It was not placed intramuscularly but rather on the soft part of my arm. I have never had any reaction like this before. It is very debilitating. On 11/11/2014 I returned to pharmacy telling them how I was still in pain and asked them to report it. They said they would. I just want to know how much longer this pain will exist and why it happened.
Age: 64.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain
Clinical narrative: The next day I realized I had difficulty sleeping on my left side as my arm up near the injection site was quite sore. This has continued since that time. I have difficulty raising my arm, lifting anything with that arm and cannot put any pressure on it like sleeping. it is worse during the night. This is continuing since I was given the Fluarix Quadrivalent injection. It was not placed intramuscularly but rather on the soft part of my arm. I have never had any reaction like this before. It is very debilitating. On 11/11/2014 I returned to pharmacy telling them how I was still in pain and asked them to report it. They said they would. I just want to know how much longer this pain will exist and why it happened.
Age: 12.0
Sex: F
Vaccine: HPV4, UNK
Symptoms: Syncope
Clinical narrative: Had syncopal episode after administration of HPV vaccine.  Laid down and received juice and crackers, and was at baseline within 20 minutes.
Age: 1.19
Sex: F
Vaccine: HEPAB, VARCEL
Symptoms: Blood test, Chest X-ray abnormal, Cough, Culture urine, Epstein-Barr virus test
Clinical narrative: Developed cough, congestion on 10/17 and fever of 102 on 10/19. Fever/cough continued thru November 8. Cough and congestion remains. CXR showed pneumonitis. WBC's elevated (increased monocytes).
Age: 1.19
Sex: F
Vaccine: HEPAB, VARCEL
Symptoms: Full blood count, Monocyte count increased, Pneumonitis, Pyrexia, Respiratory syncytial virus test
Clinical narrative: Developed cough, congestion on 10/17 and fever of 102 on 10/19. Fever/cough continued thru November 8. Cough and congestion remains. CXR showed pneumonitis. WBC's elevated (increased monocytes).
Age: 1.19
Sex: F
Vaccine: HEPAB, VARCEL
Symptoms: Respiratory tract congestion, White blood cell count increased
Clinical narrative: Developed cough, congestion on 10/17 and fever of 102 on 10/19. Fever/cough continued thru November 8. Cough and congestion remains. CXR showed pneumonitis. WBC's elevated (increased monocytes).
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Pallor, Rash papular, Rash pruritic
Clinical narrative: 3 days after rec. injectable flu vaccine the pt broke out in a rash and itching small papular rash, blances, no other symptoms.
Age: 87.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: R side neck pain and stiffness PNEUMO PPV23
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Fever starting 6 hrs after shot to 102. 48 hrs later injection had a short febrile seizure (20-30 sec) and was seen in ER.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: 5:30PM Monday after shot was fine, no reaction - Tuesday morning was fine no reaction, Tueday nite Left bicep red, warm, hard, sore 6:30 PM. Went to local ER, diagnosed with cellulitis at injection site. Put on antibiotic to LC monitor, call health dept. Call doctor. Health dept. didn't seem too concerned when called made aware situation.
Age: 14.0
Sex: M
Vaccine: FLUN4
Symptoms: Nuclear magnetic resonance imaging normal, VIIth nerve paralysis
Clinical narrative: Bells palsy.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injection site pain, Insomnia, Neck pain, Pain in extremity
Clinical narrative: Shot was given very high up on arm, was sore 4 hrs, later and next few days then spread out into shoulder and in next 5 wks, pain went to neck and down arm. I did exercises and took pain relief but neither is working to stop the hurt. Was told I have frozen shoulder. Cannot sleep on (L) side.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Periarthritis
Clinical narrative: Shot was given very high up on arm, was sore 4 hrs, later and next few days then spread out into shoulder and in next 5 wks, pain went to neck and down arm. I did exercises and took pain relief but neither is working to stop the hurt. Was told I have frozen shoulder. Cannot sleep on (L) side.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Pt reported to pharmacy on 11/13/14 complaining of shoulder pain and unable to lift  her arm very high. I told her to see her doctor.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV4
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Pallor
Clinical narrative: 1:55 pt weak, dizzy, diaphoresis, pallor. 1:56  VSS, lie down - laying down 25 min all Sx resolved.
Age: 6.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Joint swelling, Local swelling, Urticaria
Clinical narrative: Feet became red and swollen within 45 min. after receiving vaccine. Also noted 25 cent size red, itchy rash on torso. Rash progressed and spread, and hands became red and swollen also. Child was taken to urgent care facility about 1.5-2 hrs. after receiving vaccine. Dx-urticaria. Treated with BENADRYL, PEPCID and ORAPRED. Discharged to home.
Age: 6.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Erythema, Local swelling, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Feet became red and swollen within 45 min. after receiving vaccine. Also noted 25 cent size red, itchy rash on torso. Rash progressed and spread, and hands became red and swollen also. Child was taken to urgent care facility about 1.5-2 hrs. after receiving vaccine. Dx-urticaria. Treated with BENADRYL, PEPCID and ORAPRED. Discharged to home.
Age: 6.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Urticaria
Clinical narrative: Feet became red and swollen within 45 min. after receiving vaccine. Also noted 25 cent size red, itchy rash on torso. Rash progressed and spread, and hands became red and swollen also. Child was taken to urgent care facility about 1.5-2 hrs. after receiving vaccine. Dx-urticaria. Treated with BENADRYL, PEPCID and ORAPRED. Discharged to home.
Age: 62.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Syncope, Urinary incontinence
Clinical narrative: Pt received both FLUVIRIN and ZOSTAVAX at the same time. He reported feeling extremely dizzy and sat down. He fainted shortly after. He sweated and urinated while he became unconscious. He woke up about 2 minutes later and was still dizzy. Called 911 and taken away via ambulance.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Drug administered at inappropriate site
Clinical narrative: Received IM injection in hip/buttocks area patient complaining of lower back pain still a month after receiving injection.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient received flu shot 11/3/14 5:30PM. Painful going in and hurt the night thru. Patient had difficulty moving arm across chest and range of motion was diminished without pain. Patient said is better than originally was but still hurts.
Age: 66.0
Sex: M
Vaccine: FLUX, PPV, VARZOS
Symptoms: Chest pain, Feeling abnormal
Clinical narrative: This spontaneous report was received from a 66 year old male patient referring to himself. Other demographics were not reported. Concurrent conditions, medical history and allergies were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (strength, dose, route, lot number and expiration date were not reported). Concomitant therapies included TPAD, and pneumococcal vaccine (manufacturer unknown). The patient stated that on an unknown date he experienced chest pain and a feeling like he was going to die, after receiving ZOSTAVAX. No further information was provided. The outcome of chest pain and feeling like he was going to die was reported as recovered/resolved on an unknown date. Additional information is not expected, because no contact information was provided.
Age: 41.0
Sex: F
Vaccine: FLUN4
Symptoms: Eye swelling, Hypoaesthesia oral, Lip swelling, Urticaria
Clinical narrative: Patient states she noticed her lip and eye swelling and lip numbness, Hives around neck and whole body about 11:00PM, no SOB. Symptoms is getting better after took BENADRYL one hour later.
Age: 24.0
Sex: F
Vaccine: FLUC3
Symptoms: Erythema, Paraesthesia
Clinical narrative: Within a few hours of injection patient developed red spot on left arm about 2-3 inches in length complained of tingling in arm.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Pt's wife called in AM saying pt had hives 1 day post vaccine - 11/10/14. She said pt will come in to ask for how to treat hives - pt came later and showed me his hives - per back of head -> toe, arms, body -> told pt to get BENADRYL and see MD in 2 days if Sx's not persisted.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Anti-thyroid antibody, Anti-thyroid antibody negative, Antinuclear antibody negative, Blood thyroid stimulating hormone normal, Borrelia test negative
Clinical narrative: 2 days after receiving FLUMIST vaccine patient began to obsessively tic and engage in some rigid compulsive behaviors. No other triggers. Evidently it turns out there is a family history.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Full blood count normal, Metabolic function test normal, Obsessive-compulsive disorder, Serum ferritin normal, Streptococcus test negative
Clinical narrative: 2 days after receiving FLUMIST vaccine patient began to obsessively tic and engage in some rigid compulsive behaviors. No other triggers. Evidently it turns out there is a family history.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Thyroxine free normal
Clinical narrative: 2 days after receiving FLUMIST vaccine patient began to obsessively tic and engage in some rigid compulsive behaviors. No other triggers. Evidently it turns out there is a family history.
Age: 24.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Balance disorder, Dizziness, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Dizzinesss, nausea, off balance, wobbly. (R) arm (Flu shot) hot red spot 30x20 mm. (L) arm (Tdap) hot to touch, sore arm. Rx Loratadine 10 mg tabs.
Age: 24.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Nausea
Clinical narrative: Dizzinesss, nausea, off balance, wobbly. (R) arm (Flu shot) hot red spot 30x20 mm. (L) arm (Tdap) hot to touch, sore arm. Rx Loratadine 10 mg tabs.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Sore arm (muscle) lasted for 7 days.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Sore arm (muscle) lasted for 7 days.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Radioallergosorbent test negative, Rash generalised, Rash macular
Clinical narrative: This 54 year old patient reported receipt of annual FLUVIRIN (lot # 145605) on 10/17/2014 to left deltoid with no other vaccines given. Approximately 8-12 hours later (that afternoon) he noted the site was itching and red. That evening he noted red pimple like macules to his left arm, hand that progressed to his back, sides, chest, right arm/hand, legs and feet. There were no papules, vesicles or involvement of the soles of feet or palms of hands. He denied any fever, nausea, vomiting, headaches, myalgia, arthralgia, or any systemic symptoms. He denied any recent illness or exposure took no new detergents, deodorants, soaps, linen, foods, clothing, etc. He does have multiple seasonal allergies (dust, pollen, grass, mold, cats, and dogs per allergy test as child) and recently moved. He self-treated this reaction with natural element called candela gel with some relief seeking medical care on 10/21/2014. Providers diagnosed with allergic urticaria and place him on topical steroid (hydrocortisone 1% cream) with oral BENADRYL with relief of symptoms. He saw his PCP on 10/27/2014 and was referred to facility on 10/27/2014.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: This 54 year old patient reported receipt of annual FLUVIRIN (lot # 145605) on 10/17/2014 to left deltoid with no other vaccines given. Approximately 8-12 hours later (that afternoon) he noted the site was itching and red. That evening he noted red pimple like macules to his left arm, hand that progressed to his back, sides, chest, right arm/hand, legs and feet. There were no papules, vesicles or involvement of the soles of feet or palms of hands. He denied any fever, nausea, vomiting, headaches, myalgia, arthralgia, or any systemic symptoms. He denied any recent illness or exposure took no new detergents, deodorants, soaps, linen, foods, clothing, etc. He does have multiple seasonal allergies (dust, pollen, grass, mold, cats, and dogs per allergy test as child) and recently moved. He self-treated this reaction with natural element called candela gel with some relief seeking medical care on 10/21/2014. Providers diagnosed with allergic urticaria and place him on topical steroid (hydrocortisone 1% cream) with oral BENADRYL with relief of symptoms. He saw his PCP on 10/27/2014 and was referred to facility on 10/27/2014.
Age: 13.0
Sex: F
Vaccine: FLU3, HIBV, HPV4
Symptoms: Incorrect dose administered
Clinical narrative: HIB was given when it was not necessary.
Age: 37.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Developed fever day after the shots.
Age: 51.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Injection site pain, Pruritus, Swelling
Clinical narrative: Patient received PREVNAR 13 on 11/05/14 IM, LA. She came to the pharmacy at 11/13/14 with itching and redness. She said that she was swollen and that injection site was sore. MD said hot patches. I recommended cold patches and BENADRYL.
Age: 49.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 49 year old patient of unknown gender. On 26-SEP-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot number JD13137 is an invalid lot number for zoster vaccine live, expiration date 31-JAN-2015), in the left arm (dos and route not reported). The pharmacist reported that approximately in September 2014, the patient experienced localized redness that formed a circle approximately "the size of a palm" following administration of the vaccination of ZOSTAVAX on 26-SEP-2014. The reaction took approximately one week to resolve. The patient did not seek treatment for the reaction or not have any additional reactions. This is one of several reports received from the same reporter (this case concerns patient 1). Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a physician concerning his 27 year old daughter with no pertinent medical history. Drug reactions or allergies were not specified. On unspecified date in 1995, the patient was vaccinated with VARIVAX (Merck) (dose, route of administration, lot # were not reported). There were no concomitant medications. On 22-OCT-2014 (also reported as yesterday), the patient developed chickenpox. The physician reported that his daughter had about 14 or 15 chicken pox lesions present throughout her body. No treatment was given for the adverse event. No lab diagnostics studies were performed. The physician stated that his daughter had recently been traveling overseas (on unspecified dates). The outcome of chicken pox was reported as not recovered (at the time of the report). The relatedness between VARIVAX (Merck) and the event was not provided. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 2 years old patient of unknown gender. On 23-SEP-2014, the patient was vaccinated with a dose of PROQUAD (Merck) lot # K008579, expiration date 13-DEC-2015, (dose, dose number, route and frequency were not reported) that was exposed to 19.5 F for 9 hours (supported). No adverse effects were reported. No product quality complaint (PQC) involved. This is one of  the several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 years old patient of unknown gender. On 04-NOV-2014, the patient was vaccinated with a dose of PROQUAD (Merck) lot # K008579, expiration date 13-DEC-2015, (dose, dose number, route and frequency were not reported) that was exposed to 19.5 F for 9 hours (supported). No adverse effects were reported. No product quality complaint (PQC) involved. This is one of the several reports from the same source. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 55 year old female patient. The patient had no known drug allergies. No information on her medical history or concomitant drugs was reported. On 09-NOV-2014, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneously (site of administration, lot# and expiration date not reported). On 09-NOV-2014, the patient experienced redness and a slight bump at the injection site, after receiving ZOSTAVAX. The patient sought medical attention by seeing the pharmacist. No treatment was given to the patient and no lab diagnostic studies were performed. The outcome of the adverse events was unknown. The relatedness between use of ZOSTAVAX and the adverse events was not reported. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Beta haemolytic streptococcal infection, Exposure during pregnancy, Streptococcus test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to a 28 year old female patient, who was diagnosed with group B streptococcus in pregnancy (in 2014, exact date unspecified), fibrocystic disease of the breast and none drug reactions or allergies. On 11-NOV-2014 the patient was inadvertently vaccinated with VARIVAX (Merck) (lot # K002913, expiry date: 26-FEB-2016, dose, units, route of administration, anatomical location were not reported). None concomitant medication were reported. The patient became pregnant with LMP (last menstrual period) of 21-AUG-2014 (reported as 11 weeks and 5 days) and EDD (estimated delivery date) of 28-MAY-2015. Initial exposure to VARIVAX (Merck) was at 11 weeks. The pregnancy outcome was not reported. It was reported that none treatment was given for the adverse event. It was reported that none diagnostics studies were performed. The patient did not seek medical attention. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Measles antibody negative, Measles antibody positive, Mumps antibody test positive, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 56 year old female patient with allergy to erythromycin, allergy to penicillin, rheumatoid arthritis. The pharmacist stated that she was unsure if the patient had ever received a dose of M-M-R II prior tot he dose she received on 01-OCT-2014. On 01-OCT-2014 the patient was vaccinated with M-M-R II serum albumin (HSA) (lot # J013069, expiration date 16-OCT-2014, 0.5 ml, subcutaneously) due to having serology testing dose on an unspecified date that showed that the patient was immune to mumps and measles but not to rubella. Concomitant therapies included prednisone (manufacturer unknown), methotrexate (manufacturer unknown), hydroxychloroquine sulfate, metoprolol (also reported as TOPROLOL), aspirin (also reported as baby aspirin) and atorvastatin. On 20-OCT-2014 the patient developed unspecified itchy rash on her arms, face, neck and trunk as well as unspecified joint pain and fever. There was no lab diagnostic studies performed. The physician informed that as a treatment the patient took unspecified non-steroidal anti-inflammatory drugs (NSAID's) and antihistamines as needed on 25-OCT-2014. The pharmacist reported that the rash was almost gone since an unspecified date, the outcomes of the events were also reported as recovering. The patient sought medical attention and was seen by the physician on 25-OCT-2014. The relatedness between the events and M-M-R II was not reported. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 56 year old female patient with allergy to erythromycin, allergy to penicillin, rheumatoid arthritis. The pharmacist stated that she was unsure if the patient had ever received a dose of M-M-R II prior tot he dose she received on 01-OCT-2014. On 01-OCT-2014 the patient was vaccinated with M-M-R II serum albumin (HSA) (lot # J013069, expiration date 16-OCT-2014, 0.5 ml, subcutaneously) due to having serology testing dose on an unspecified date that showed that the patient was immune to mumps and measles but not to rubella. Concomitant therapies included prednisone (manufacturer unknown), methotrexate (manufacturer unknown), hydroxychloroquine sulfate, metoprolol (also reported as TOPROLOL), aspirin (also reported as baby aspirin) and atorvastatin. On 20-OCT-2014 the patient developed unspecified itchy rash on her arms, face, neck and trunk as well as unspecified joint pain and fever. There was no lab diagnostic studies performed. The physician informed that as a treatment the patient took unspecified non-steroidal anti-inflammatory drugs (NSAID's) and antihistamines as needed on 25-OCT-2014. The pharmacist reported that the rash was almost gone since an unspecified date, the outcomes of the events were also reported as recovering. The patient sought medical attention and was seen by the physician on 25-OCT-2014. The relatedness between the events and M-M-R II was not reported. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site urticaria, Pruritus generalised, Urticaria
Clinical narrative: Hives appeared at injection site 3 days after administration. Hives spread to upper back/shoulder. Pt with full body itching requiring BENADRYL. Symptoms persisting 1 week after vaccine.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified amount of patients of unknown age and gender. On an unknown dates the patients were vaccinated with doses of Oral, ROTATEQ that underwent temperature excursions. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Rash 2" x 6" rectangle. Red, raised, warm.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Rash 2" x 6" rectangle. Red, raised, warm.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 67 years old female patient. On 04-NOV-2014 the patient was vaccinated with a dose of ZOSTAVAX lot # K009198, expiry date: 27-SEP-2015, 0.65 ml, subcutaneously. The pertinent patient's medical history and drug allergies/reactions were not reported. The concomitant medication included cortisone (reported as used "sometime in the past (unspecified date)"). On an unknown date the patient developed an injection site reaction of redness and pain. The injection site area also felt hard. The patient sought a medical attention and called the pharmacist. There was no laboratory tests performed. The outcome of the events were reported as not recovered/not resolved. The causality between ZOSTAVAX and the events was not reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as receive from a other health professional refers to a 61 year old female patient. On 29-OCT-2014 the patient was vaccinated with ZOSTAVAX (dose, frequency, lot # unknown). Other suspect therapies included (Oka/Merck) VARIVAX. The patient was scheduled to receive her second dose of (oka/Merck) VARIVAX on 29-OCT-2014 but received a dose of ZOSTAVAX. The healthcare worker believed that the error occurred because the patient is of the age-range to receive ZOSTAVAX, and the error probably did not occur due to medication confusion. The patient had not reported or demonstrated any adverse effects. The outcome of events was unknown. Product quality was not reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Local swelling
Clinical narrative: Whole arm swelled, Dr asked us to report not sure if treated.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised, Rash macular
Clinical narrative: Red blotches all over body in different location. Itchy all over body. No problem at site of injections.