chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Chest discomfort, Dyspnoea, Injection site reaction, Pallor, Vomiting
Clinical narrative: Pt C/O difficulty breathing, skin red initially, stated he was having a reaction - given 0.3 EPIPEN 0802. Became diaphoretic and pallor.  Placed in supine position and monitored. VS: 0800, 165/100, 92; 0805, 163/88, 101, O2 sats 91; 0820, 118/53, 95, O2 sats 95; 0830, 141/78, 102.  EPIPENS 5GM401 2/17.
Age: 20.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Dyspnoea, Erythema, Hyperhidrosis, Pallor
Clinical narrative: Pt C/O difficulty breathing, skin red initially, stated he was having a reaction - given 0.3 EPIPEN 0802. Became diaphoretic and pallor.  Placed in supine position and monitored. VS: 0800, 165/100, 92; 0805, 163/88, 101, O2 sats 91; 0820, 118/53, 95, O2 sats 95; 0830, 141/78, 102.  EPIPENS 5GM401 2/17.
Age: 47.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Injection site pain, Joint range of motion decreased, Pain
Clinical narrative: Arm pain, constant, worsens as the day goes on. Limited range of motion.
Age: 47.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Arm pain, constant, worsens as the day goes on. Limited range of motion.
Age: 89.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Blood test, Cellulitis, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: As reported by daughter, a few hours after the vaccination, swelling occurred in the arm. It continued to swell and become painful to the point that the patient went to the emergency room. She was diagnosed with cellulitis, spent 12 hours in the ER under evaluation, then was admitted overnight. She was released on 10/27/2016 and had to return for IV antibiotics as an outpatient once daily for the following 7 days.
Age: 89.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Pain in extremity, Peripheral swelling
Clinical narrative: As reported by daughter, a few hours after the vaccination, swelling occurred in the arm. It continued to swell and become painful to the point that the patient went to the emergency room. She was diagnosed with cellulitis, spent 12 hours in the ER under evaluation, then was admitted overnight. She was released on 10/27/2016 and had to return for IV antibiotics as an outpatient once daily for the following 7 days.
Age: 59.0
Sex: M
Vaccine: FLU3, FLUX, FLU3
Symptoms: Hypoaesthesia, Injection site hypoaesthesia
Clinical narrative: Influenza vaccine administered Nov 11, 2016, via left deltoid site. At 48 hours postvax pt noted paresthesia (numbness of entire left arm from shoulder through hand. At 72 hrs, mild (L) left paresthesia.
Age: 59.0
Sex: M
Vaccine: FLU3, FLUX, FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Influenza vaccine administered Nov 11, 2016, via left deltoid site. At 48 hours postvax pt noted paresthesia (numbness of entire left arm from shoulder through hand. At 72 hrs, mild (L) left paresthesia.
Age: 59.0
Sex: M
Vaccine: FLU3, FLUX, FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Influenza vaccine administered Nov 11, 2016, via left deltoid site. At 48 hours postvax pt noted paresthesia (numbness of entire left arm from shoulder through hand. At 72 hrs, mild (L) left paresthesia.
Age: 1.25
Sex: M
Vaccine: DTAP, FLUX, VARCEL
Symptoms: Injection site abscess, Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Developed reddened hard area that was tender to touch and had a large lump in right leg at injection site. Went to doctor and diagnosed an abscess. 1inx1in.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Left deltoid pain, preventing patient from doing push-ups and other physical training.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Crying, Staring
Clinical narrative: Excessive crying and staring spell.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Paraesthesia
Clinical narrative: Initial unsolicited report received from a pharmacist on 03-Nov-2016. This case involves a 68-year-old patient (gender not reported) who was vaccinated with FLUZONE HD via intramuscular route (batch number: UI703AA, expiry date: 08-May-2017; dose, dose in series not reported) at left deltoid on 03-Oct-2016. Patient's illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was not reported. Concomitant medications were not reported. On 16-Oct-2016, 13-day after vaccination, patient experienced tingling in fingertips and diagnosed with Guillain Barre Syndrome. Patient was hospitalized on an unknown date. Patient required ER/doctor visit on 20 Oct 2016. Lab data and corrective treatment was not reported. The outcome of the events were reported as unknown. List of documents held by sender: none. Sender's Comments: GBS was suspected in this case after vaccination with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, however diagnosis was not confirmed. Time to onset (13 Days) is compatible with a role of the vaccine. GBS is listed with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. To be noted that GBS is often preceded by an gastrointestinal or respiratory infection which was not ruled out in this case. Details regarding relevant medical history, as well as infectious work-up and information on infections occurring prior to vaccination are needed for complete assessment of the case. Based on the available information, no conclusion on the role of the vaccine can be drawn.
Age: 7.0
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Eye swelling, Injection site swelling, Lip swelling, Pruritus
Clinical narrative: Initial unsolicited report received from a physician on 05 Nov 2016. This case involves a seven years old patient (gender- unknown) who was vaccinated with a dose of FLUZONE QIV (Batch number, expiry date, dose, dose in series, and route of administration- unknown) at arm on 04 Nov 2016. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. Concomitant medications was not reported. On 04 Nov 2016, on the same day following the vaccination, patient developed extensive widespread hives over the body and injection site swelling. Patient's upper lip was swollen. The patient had bilateral periorbital swelling, the injection site swelling covered the whole upper arm to the elbow. Hives were red, and itchy but no difficulty on breathing. The patient required Emergency room doctor visit. Laboratory investigations were not reported. The patient received corrective treatment with BENADRYL. The outcome of the events were recovering (reported as patient's condition was improving). List of documents held by sender: none.
Age: 7.0
Sex: U
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Initial unsolicited report received from a physician on 05 Nov 2016. This case involves a seven years old patient (gender- unknown) who was vaccinated with a dose of FLUZONE QIV (Batch number, expiry date, dose, dose in series, and route of administration- unknown) at arm on 04 Nov 2016. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. Concomitant medications was not reported. On 04 Nov 2016, on the same day following the vaccination, patient developed extensive widespread hives over the body and injection site swelling. Patient's upper lip was swollen. The patient had bilateral periorbital swelling, the injection site swelling covered the whole upper arm to the elbow. Hives were red, and itchy but no difficulty on breathing. The patient required Emergency room doctor visit. Laboratory investigations were not reported. The patient received corrective treatment with BENADRYL. The outcome of the events were recovering (reported as patient's condition was improving). List of documents held by sender: none.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Gastrointestinal disorder, Hyperhidrosis, Injection site pain, Pyrexia
Clinical narrative: Initial unsolicited report received from a consumer on 05 November 2016. This case involves 74-year-old female patient, who was vaccinated with a dose of FLUZONE HD (batch number, expiration date, dose, dose series and site of administration were not reported) via intramuscular route on 01 November 2016. The patient's illness at time of vaccination: denies and pre-existing physician diagnosed allergies, birth defects and medical conditions were not provided (no known allergies). Concomitant medication reported as none. On 01 November 2016, straight away following vaccination, patient had runny nose. On 04 November 2016, in the morning three days following vaccination, patient's arm really hurt at the injection site, she had a low grade fever, with sweats intermittently and felt really bad. On an unspecified date following vaccination patient experienced some issues with her bowels. Laboratory data and corrective treatment were reported as none. Outcome of the events was reported as unknown. List of documents held by sender: none.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Rhinorrhoea
Clinical narrative: Initial unsolicited report received from a consumer on 05 November 2016. This case involves 74-year-old female patient, who was vaccinated with a dose of FLUZONE HD (batch number, expiration date, dose, dose series and site of administration were not reported) via intramuscular route on 01 November 2016. The patient's illness at time of vaccination: denies and pre-existing physician diagnosed allergies, birth defects and medical conditions were not provided (no known allergies). Concomitant medication reported as none. On 01 November 2016, straight away following vaccination, patient had runny nose. On 04 November 2016, in the morning three days following vaccination, patient's arm really hurt at the injection site, she had a low grade fever, with sweats intermittently and felt really bad. On an unspecified date following vaccination patient experienced some issues with her bowels. Laboratory data and corrective treatment were reported as none. Outcome of the events was reported as unknown. List of documents held by sender: none.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Abdominal pain upper, Activities of daily living impaired, Body temperature increased, Dyspnoea, Gastrointestinal pain
Clinical narrative: This spontaneous report as received from a consumer (patient's father) refers to his 12 and half year old daughter (at the time of reporting the patient was 13 years of age). The patient's pertinent medical history included exercise induced asthma and jaundiced at birth. On an unknown date approximately in May 2016 (reported as about six months ago, when the patient was twelve and half years of age), the patient was vaccinated with the first dose of Quadrivalent Human Papillomavirus (yeast) (could not be confirmed GARDASIL or GARDASIL 9) injection. On unspecified date of approximately May 2016 (reported as within "a week to week and one half" after receiving the first dose in the GARDASIL series), the patient developed a "high fever and gut ache". At an unspecified time after the first dose in the GARDASIL or GARDASIL 9 series, the patient was seen in an unspecified emergency room. The patient's abdomen was examined, and she was diagnosed with an "enlarged spleen/splenomegaly". "Mononucleosis was suspected" by the emergency room personnel, and unspecified blood work was performed. The blood work "turned out negative for mononucleosis". On an unspecified date approximately in July 2016 (reported as "Two months later"), the patient had the second dose in the GARDASIL or GARDASIL 9 series. About a week later, approximately July 2016, she had a 102 degree temperature (units not provided). The patient was sent for an "ultrasound on the spleen". The spleen was "still enlarged". About two weeks after the second shot (unspecified date of 2016), the patient "almost died because she could not breathe". She was in good shape and all of a sudden she could not breathe. It was "like she was drowning". The reporter treated the patient with her [unspecified] inhaler that she uses for exercise induced asthma. This was something the reporter had never seen in her before. The patient had the last dose in the GARDASIL or GARDASIL 9 series four to five weeks ago (unspecified date of approximately October 2016). The next day (unspecified date of October 2016), the patient complained of gut ache near the spleen. The patient had another ultrasound and as of the time of this report, her "spleen was still enlarged". The patient was now scheduled to be examined by a hematologist. The patient could not play soccer or go to her horse camp because the possibility that her spleen could rupture. The patient did not receive any treatment for the reported events. The outcome of splenomegaly was not recovered and outcome of other events were unknown. Causality assessment was not provided. No product quality complaint (PQC) was reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Mononucleosis heterophile test negative, Pyrexia, Splenomegaly, Ultrasound scan abnormal
Clinical narrative: This spontaneous report as received from a consumer (patient's father) refers to his 12 and half year old daughter (at the time of reporting the patient was 13 years of age). The patient's pertinent medical history included exercise induced asthma and jaundiced at birth. On an unknown date approximately in May 2016 (reported as about six months ago, when the patient was twelve and half years of age), the patient was vaccinated with the first dose of Quadrivalent Human Papillomavirus (yeast) (could not be confirmed GARDASIL or GARDASIL 9) injection. On unspecified date of approximately May 2016 (reported as within "a week to week and one half" after receiving the first dose in the GARDASIL series), the patient developed a "high fever and gut ache". At an unspecified time after the first dose in the GARDASIL or GARDASIL 9 series, the patient was seen in an unspecified emergency room. The patient's abdomen was examined, and she was diagnosed with an "enlarged spleen/splenomegaly". "Mononucleosis was suspected" by the emergency room personnel, and unspecified blood work was performed. The blood work "turned out negative for mononucleosis". On an unspecified date approximately in July 2016 (reported as "Two months later"), the patient had the second dose in the GARDASIL or GARDASIL 9 series. About a week later, approximately July 2016, she had a 102 degree temperature (units not provided). The patient was sent for an "ultrasound on the spleen". The spleen was "still enlarged". About two weeks after the second shot (unspecified date of 2016), the patient "almost died because she could not breathe". She was in good shape and all of a sudden she could not breathe. It was "like she was drowning". The reporter treated the patient with her [unspecified] inhaler that she uses for exercise induced asthma. This was something the reporter had never seen in her before. The patient had the last dose in the GARDASIL or GARDASIL 9 series four to five weeks ago (unspecified date of approximately October 2016). The next day (unspecified date of October 2016), the patient complained of gut ache near the spleen. The patient had another ultrasound and as of the time of this report, her "spleen was still enlarged". The patient was now scheduled to be examined by a hematologist. The patient could not play soccer or go to her horse camp because the possibility that her spleen could rupture. The patient did not receive any treatment for the reported events. The outcome of splenomegaly was not recovered and outcome of other events were unknown. Causality assessment was not provided. No product quality complaint (PQC) was reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Joint swelling, Skin warm
Clinical narrative: Upper arm swelled on the inside of the arm from a couple of inches below the armpit to elbow, turned red, was hot to the touch. Applied cool compresses.
Age: 89.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm redness, soreness, swelling, and warm to touch. Symptoms worsened with redness and swelling extending beyond elbow into left forearm. Pt went to ER and was diagnosed with cellulitis.
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Herpes zoster, Lymphadenopathy, Musculoskeletal stiffness, Pain, Rash
Clinical narrative: Was diagnosed with Shingles. I had a Stiff Neck, Extremely Swollen Lymph Nodes, Rash forming on Right side of forehead and right eyelid, very sluggish, and a lot of pain. Each say the rash was getting larger and causing more swelling.
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Sluggishness
Clinical narrative: Was diagnosed with Shingles. I had a Stiff Neck, Extremely Swollen Lymph Nodes, Rash forming on Right side of forehead and right eyelid, very sluggish, and a lot of pain. Each say the rash was getting larger and causing more swelling.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal distension, Diarrhoea, Flatulence, Nausea, Pyrexia
Clinical narrative: Fever, nausea, Bloating, Gas, Diarrhea.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Abasia, Diarrhoea, Headache, Injection site pain, Laboratory test normal
Clinical narrative: Severe vomiting; SEVERE lethargy; little diarrhea; mild fever initially and going up to 103F; severe leg pain; no rash at injection site. Patient will not walk. Headaches.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Lethargy, Pyrexia, Vomiting
Clinical narrative: Severe vomiting; SEVERE lethargy; little diarrhea; mild fever initially and going up to 103F; severe leg pain; no rash at injection site. Patient will not walk. Headaches.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Nuclear magnetic resonance imaging, X-ray limb
Clinical narrative: Severe right shoulder pain.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Pallor, Syncope
Clinical narrative: Syncope: (Paleness, Sweating, Lightheadedness). Treatment: Cold Compresses Applied to patient's head, and neck.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Death, Disseminated intravascular coagulation
Clinical narrative: Initial unsolicited report received from a nurse on 09 Nov 2016. This case involves a 63-year-old female patient who was vaccinated with a dose of FLUZONE MULIT-DOSE VIAL QIV (batch number: U1678AB, expiry date: 30 Jun 2017, route, site and dose not reported) on 31 Oct 2016. Patient had previous history of coagulation disorder. Concomitant medications were not provided. On an unspecified date, post vaccination, the patient had DIC (Disseminated Intravascular Coagulation). On 03 Nov 2016, patient went to emergency room. Lab data includes full vitals, blood planel review and blood was drawn on 18 Oct 2016. Corrective treatment was not reported. On 04 Nov 2016, the patient passed away. List of documents held by sender: none.; Sender's Comments: This is a poorly documented death case where patient passed away from DIC (Disseminated Intravascular Coagulation) after administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. It was to be noted that the patient had previous history of coagulation disorder of unknown etiology. The detailed autopsy report, detailed past medical history, concomitant medication and immune status at the time of vaccination would be helpful to assess this case further.; Reported Cause(s) of Death: Disseminated Intravascular Coagulation.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Injection site reaction
Clinical narrative: There was instant pain when the shot was given, it was also given a little higher on my arm than normal. My right arm was very sore and got more so as time went on. I have limited movement of my arm due to severe soreness in the muscle area.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain
Clinical narrative: No pain with injection, after a few hours couldn't bring arm up with elbow over shoulder. Still having pain with crossing arm over shoulder like to take shirt off. Pt feels injection was given too high.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Chills, Crying, Pain in extremity, Pyrexia
Clinical narrative: Mom called to report adverse side effects after receiving vaccinations on 11/3/16. Received flu, Men B, and MENACTRA at appointment. About 7pm, mom states he spike a fever of 102.5 for 30 min to 1 hour with low grade fever for rest of night; gave 1 dose of TYLENOL; chills; crying; pain in left arm for about a week. Fever and chills resolved overnight.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Facial paralysis
Clinical narrative: Patient complained of facial droop 10/29/16; given history of DVT and PE he was transferred to a Medical Center, evaluated for stroke and neurological deficits and diagnosed with Bell's Palsy.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: WHILE THERE WAS INITIAL ARM/MUSCLE PAIN AT THE INJECTION SITE THAT WORE OFF AFTER 2-3 DAYS. SHOOTING ARM PAIN AND LIMITED RANGE OF MOTION BEGAN AS THE STEROID TAPER CAME TO AN END. IT HAS CONTINUED TO PRESENT. THERE IS A DULL ACHE AT THE INJECTION SITE WITH SHARP SHOOTING PAINS WITH MOTION.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Erythema, Skin discolouration
Clinical narrative: Symptoms began with a redness, slowly progressed to a larger area. The middle is now white with a purple spot, with surrounding redness.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Dyspnoea
Clinical narrative: Couldn't breathe well the night of the HPV vaccine #1.
Age: 20.0
Sex: M
Vaccine: ANTH, IPV, TYP
Symptoms: Syncope
Clinical narrative: Syncope reaction. Did not have breakfast prior to vaccination.
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Diarrhoea, Headache, Nausea, Pain
Clinical narrative: Fever, chills, aches, nausea, diarrhea, headache, photosensitivity in eyes.
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Photosensitivity reaction, Pyrexia
Clinical narrative: Fever, chills, aches, nausea, diarrhea, headache, photosensitivity in eyes.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Patient stated she was having an incredible pain she had never felt before. Someone came in from the parking lot and told a store manager. The store manager called an ambulance then came over to the pharmacy to let me know what was going on. Patient was in her car in the parking lot. I was giving other vaccinations so I sent my technician out with an Epipen. When we got out there, the ambulance was already there. I went out when she got back and spoke to the patient and the ambulance drivers. She was not having any problems at that point. They checked her over and I called later that night to check on her and she was doing great.
Sex: F
Vaccine: FLU4
Symptoms: Dermatitis atopic, Dermatitis diaper, Eczema, Foetal exposure during pregnancy, Irritability
Clinical narrative: Extreme fussiness since she was born, eczema onset showed two weeks after she was born and has gotten progressively worse over (she is currently five months old). Terrible sleeping due to extreme itching all over her body. Eczema patches all over her body (face, chest, abdomen, legs, arms, back), including diaper rash. She has been diagnosed with Atopic Eczema. Possible food/environmental allergies. Cradle cap for the first two-three months. I have tried all sorts of treatments: Baby's JarroDophilus probiotics (drops), Kid-e-Col for colic and teething, aloe vera lotion, Vitamin E oil, Cera Ve moisturizing cream (active ingredient: dimethicone 1.2%) Aveeno colloidal oatmeal bath, Aquaphor diaper rash cream, Jojoba oil, my own breastmilk, Eucerin eczema relief for babies (active ingredient: colloidal oatmeal 1%), Tom's baby sunscreen lotion (active ingredient: zinc oxide 20%), extra virgin olive oil, apple cider vinegar (Bragg organic), Organic Virgin Coconut Oil (cold pressed and unrefined), pure Shea butter, lavender essential oil, pure castille soap for babies, 99% certified active aloe whole leaf aloe vera mixture Aloe Life skin gel, bees wax, 1% hydrocortisone over the counter, neosporin, VitD drops, sun therapy, diet changes to organic....
Sex: F
Vaccine: FLU4
Symptoms: Poor quality sleep, Pruritus generalised, Seborrhoeic dermatitis
Clinical narrative: Extreme fussiness since she was born, eczema onset showed two weeks after she was born and has gotten progressively worse over (she is currently five months old). Terrible sleeping due to extreme itching all over her body. Eczema patches all over her body (face, chest, abdomen, legs, arms, back), including diaper rash. She has been diagnosed with Atopic Eczema. Possible food/environmental allergies. Cradle cap for the first two-three months. I have tried all sorts of treatments: Baby's JarroDophilus probiotics (drops), Kid-e-Col for colic and teething, aloe vera lotion, Vitamin E oil, Cera Ve moisturizing cream (active ingredient: dimethicone 1.2%) Aveeno colloidal oatmeal bath, Aquaphor diaper rash cream, Jojoba oil, my own breastmilk, Eucerin eczema relief for babies (active ingredient: colloidal oatmeal 1%), Tom's baby sunscreen lotion (active ingredient: zinc oxide 20%), extra virgin olive oil, apple cider vinegar (Bragg organic), Organic Virgin Coconut Oil (cold pressed and unrefined), pure Shea butter, lavender essential oil, pure castille soap for babies, 99% certified active aloe whole leaf aloe vera mixture Aloe Life skin gel, bees wax, 1% hydrocortisone over the counter, neosporin, VitD drops, sun therapy, diet changes to organic....
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Headache, Pain
Clinical narrative: Severe headaches which has not subsided; severe vomitting, severe diarrhea and stomach cramps, body aches, fever, chills.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Severe headaches which has not subsided; severe vomitting, severe diarrhea and stomach cramps, body aches, fever, chills.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Abnormal dreams, Contusion, Injection site bruising, Injection site pain, Injection site reaction
Clinical narrative: Easy severe bruising throughout the body, from ankle to injection site. (Bruises that were dark and lasted for almost two weeks, that usually would not be there, or didn't really have an explanation as to how they occurred.) Injection site sting pain continued for 3 weeks, ie; a sting feeling, each time it was rubbed. From Injection site muscle to bottom of neck, entire strap of muscle was very tense, like a constant charley horse pain. Muscle ache pain was felt into spine near neck. Really Really Really weird dreams when muscle was aching during sleep.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle spasms, Tension
Clinical narrative: Easy severe bruising throughout the body, from ankle to injection site. (Bruises that were dark and lasted for almost two weeks, that usually would not be there, or didn't really have an explanation as to how they occurred.) Injection site sting pain continued for 3 weeks, ie; a sting feeling, each time it was rubbed. From Injection site muscle to bottom of neck, entire strap of muscle was very tense, like a constant charley horse pain. Muscle ache pain was felt into spine near neck. Really Really Really weird dreams when muscle was aching during sleep.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Bad body aches for 24 hours, swelling pain and redness from shot injection site to elbow, hot to touch, still remains as of 11/16/16 but improving.
Age: 0.5
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: Dyspnoea
Clinical narrative: Child had extreme difficulty breathing. Mother took child to the ER. No EPI was given in the ER. Benadryl IM was given with much relief.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: No breathing difficulties. Caller reports that child woke up the next morning with skin around the vaccination site described as hot, red and raised. The redness spread from the injection site to the shoulder and down to the elbow. Child was taken to HCP today for treatment.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Oropharyngeal pain, Sneezing, Vomiting
Clinical narrative: Patient states feeling weak, throwing up, sore throat, and sneezing.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Typical arm soreness that I have experienced in years past with a flu shot. However, the pain is still present to the right arm and range of motion is still not to baseline.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Febrile convulsion, Tonic convulsion
Clinical narrative: Tonic Seizure, Complex Febrile Seizure lasting 45 minutes - 1 hour.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Mother reports patient was in his usual state of health on 15 November 2016 and received his seasonal influenza vaccine (FLUARIX) in his left shoulder without immediate adverse reaction. On the morning of 16 November 2016 he was noted to have redness, swelling, and tenderness of his left upper arm just below the vaccination site. Mother denies a prior history of egg allergy and adverse vaccine reaction (he has previously received and tolerated vaccines to include influenza without adverse reaction). No current medications. No history of trauma to site. No use of contactants at affected site. Patient and his mother deny fever/chills, painful/swollen joints, aches, fatigue/malaise, rhinoconjunctival, laryngeal, pulmonary, GI, neurologic, and CV symptoms. No painful/swollen joints. Treated with supportive/symptomatic measures, oral antihistamine, and oral NSAID.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Seizure
Clinical narrative: Seizures post vaccination on 01/16/2015 and at 12:40 a.m. and 1:27 a.m. on  01/17/2015.  Called 911 on 01/16/2015, but they did not come out as seizure eventually subsided.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Joint swelling
Clinical narrative: Headache and swelling in my Elbow.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Muscle contractions involuntary, Seizure
Clinical narrative: Date and time not documented.  Child's left fist became clenched and patient was having a seizure.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Hyperhidrosis, Lethargy, Pallor, Presyncope
Clinical narrative: Diaphoresis, Lethargy, Pallor (Near Syncope).
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Headache, Laboratory test normal, Syncope
Clinical narrative: Dizzy, fainted, headaches.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Neck pain
Clinical narrative: Pain in right arm at injection site, shoulder and neck. Pain in these areas continue to this day. Use of right arm decreased. Taking ASA 3-4 times a day for the pain.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Deafness, Ear infection, Influenza virus test negative, Malaise
Clinical narrative: Severe sore throat inflammation. Severe ear infection with 50% hearing loss. Chest congestion and racking cough. Nausea and vomiting.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Mononucleosis heterophile test negative, Nausea, Oropharyngeal pain, Pharyngeal inflammation, Respiratory tract congestion
Clinical narrative: Severe sore throat inflammation. Severe ear infection with 50% hearing loss. Chest congestion and racking cough. Nausea and vomiting.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Streptococcus test negative, Vomiting
Clinical narrative: Severe sore throat inflammation. Severe ear infection with 50% hearing loss. Chest congestion and racking cough. Nausea and vomiting.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Information has been received from a physician via a company representative referring to a 12 year old male patient. The patient had no pertinent medical history or drug reactions/allergies. On 11-NOV-2016 the patient was vaccinated with the first dose of GARDASIL 9 (lot # M017983, expiry date 30-MAY-2018, intramuscular in the left deltoid; dose unknown). Concomitant therapies included FLUZONE which was administered in the left deltoid on the same day. The patient fainted after administration of GARDASIL 9. The patient was "unconscious for about 10 seconds or less then came to quickly". He recovered in office. He had some granola bars and some fruit juice in the office as treatment. About 30-40 minutes later, he was released from the office with no lab diagnostic studies were performed. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus generalised
Clinical narrative: Pt has numerous red, itchy spots all over her body. She also, however, started taking tramadol around the same time as the vaccination, but she states she had taken tramadol before. She has also had the flu shot in years past. She has taken BENADRYL and used hydrocortisone as of 11/15/16, and had not contacted her doctor.
Age: 26.0
Sex: M
Vaccine: HPV9
Symptoms: Aphthous ulcer
Clinical narrative: Aphthous ulcer.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pruritus, Injection site bruising, Musculoskeletal stiffness, Pruritus, Rash
Clinical narrative: Itching, injection site large circular bruise, stiff right arm muscle, itching in eyes, large rash on chest and legs and shoulder.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Breast pain, Breast tenderness, Pain
Clinical narrative: Pt had no symptoms until November 5, 2016 and at 3:30 PM when you walking and felt burning pain in left breast which was intermittent.  Since that time it has become more regular, and daily, not constant, tenderness especially with moving her left arm.  The pain is isolated to the breast.
Age: 11.0
Sex: F
Vaccine: HPV9, MMR, TDAP
Symptoms: Injection site erythema
Clinical narrative: PT 6.5 CM RED AREA AT SITE OF TDap no fever. Rx for Benadryl f/u on 11/17/16.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Drug administered at inappropriate site, Hypoaesthesia, Injected limb mobility decreased, Injection site discomfort
Clinical narrative: Provider administered shot while standing, with myself seated, placed the shot too high. Suspect SIRVA. Injection of vaccine was administered on the upper portion of deltoid, very near shoulder. There was a popping feeling in shoulder when needle was placed. By the evening, the upper arm and shoulder was extremely sore, range of motion was limited due to pain. The soreness did not subside, and instead got worse. Range of motion became more limited, occasional numbness in fingers and hands, shooting, tingling hot pain, cannot sleep on left side, difficulty nursing baby, lifting children, even a month out. Dr appt scheduled for 11/21/16.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site injury, Injection site pain, Pain, Paraesthesia, Sleep disorder
Clinical narrative: Provider administered shot while standing, with myself seated, placed the shot too high. Suspect SIRVA. Injection of vaccine was administered on the upper portion of deltoid, very near shoulder. There was a popping feeling in shoulder when needle was placed. By the evening, the upper arm and shoulder was extremely sore, range of motion was limited due to pain. The soreness did not subside, and instead got worse. Range of motion became more limited, occasional numbness in fingers and hands, shooting, tingling hot pain, cannot sleep on left side, difficulty nursing baby, lifting children, even a month out. Dr appt scheduled for 11/21/16.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Decreased appetite, Dizziness, Fatigue, Feeling cold, Headache
Clinical narrative: Chills, dizzy, headache, fatigue, drowsy, nausea, decreased appetite. Inj site warm, red and started swelling night of injection. Patient did not call office until 11/16/2016 to be seen, where she was noted to have cellulitis from inj site to elbow on right arm.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Chills, dizzy, headache, fatigue, drowsy, nausea, decreased appetite. Inj site warm, red and started swelling night of injection. Patient did not call office until 11/16/2016 to be seen, where she was noted to have cellulitis from inj site to elbow on right arm.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Somnolence
Clinical narrative: Chills, dizzy, headache, fatigue, drowsy, nausea, decreased appetite. Inj site warm, red and started swelling night of injection. Patient did not call office until 11/16/2016 to be seen, where she was noted to have cellulitis from inj site to elbow on right arm.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Arm has been sore since shot given, currerntly 11/16/16 (21 days).
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Cardiac function test normal, Electrocardiogram normal, Full blood count normal, Glomerular filtration rate normal, Metabolic function test normal
Clinical narrative: Pt arrived @ ER on 11/4/16 @ 17:40. Husband reports pt seizing and unresponsive prior to calling 911 5 minutes earlier. Work up benign. d/c ER 11/4/16 @ 1900. Diagnosis: reaction to vaccine.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Seizure, Unresponsive to stimuli, Urine analysis normal, Vaccination complication
Clinical narrative: Pt arrived @ ER on 11/4/16 @ 17:40. Husband reports pt seizing and unresponsive prior to calling 911 5 minutes earlier. Work up benign. d/c ER 11/4/16 @ 1900. Diagnosis: reaction to vaccine.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Feeling cold, Pyrexia, Tremor, Vomiting
Clinical narrative: Weakness, sudden onset of extreme and uncontrollable shaking, cold, high fever (up to 103)and vomiting later in night.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal stiffness, Myalgia
Clinical narrative: Patient reports muscle was severely painful and stiff starting later in the day of the vaccine which progressed over a few days, then chronically remained stiff and sore with periodic worsening can even limit range of motion.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: REDDNESS AND SWELLING AT INJECTION SITE.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Bedridden, Feeling abnormal, Feeling cold, Nausea, Pyrexia
Clinical narrative: Chills, fever (102), nausea, bed-ridden 36 hrs. Felt bad another 24hrs. Had same reaction in 2014-with the high dose flu shots-2015 No reaction w/regular shot.
Age: 0.5
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Injection site paraesthesia, Paraesthesia
Clinical narrative: Approx. 5 min after administration of vaccine. Pt C/O tingling in arm and at site (L) arm and dizziness. Escorted to nurses office.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Balance disorder, Feeling cold, Head discomfort, Hyperhidrosis, Hypoaesthesia
Clinical narrative: Left arm weak and left leg numbness, feeling off balance. Right side of head feeling pressure. (L) upper arm tingling, shaky, cold sweaty.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Nervousness, Paraesthesia
Clinical narrative: Left arm weak and left leg numbness, feeling off balance. Right side of head feeling pressure. (L) upper arm tingling, shaky, cold sweaty.
Sex: U
Vaccine: MENB
Symptoms: Musculoskeletal stiffness, Syncope
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer sales representative. A patient of unspecified age and gender received a single dose of TRUMENBA, via an unspecified route of administration on  an unspecified date for immunisation.  The patient medical history and concomitant medications were not reported.  On an unspecified date, after vaccination, the patient fainted and limbs became stiff. The final outcome of the events was unknown.
Age: 64.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer reported for himself. A 64-year-old male patient received PREVNAR 13 for immunization on 07Nov2016 07:00 at single dose via an unspecified route on the right arm. Medical history included laminectomy since 08Aug2016 and ongoing. On 03Oct2016 the patient got the influenza vaccine. Concomitant medication included gapapentin for spinal laminectomy at 300 mg, 3x/day orally and ongoing. On 11Nov2016 the patient experienced that the injection site was all red and hard, on his chest, neck and top of his back, he was breaking out of hives, swelling at the injection site and pain at the injection site. The outcome of the events was not recovered. The patient received treatment only for pain with Tylenol.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Pyrexia, Vaccination site swelling
Clinical narrative: This is a spontaneous report from  a contactable pharmacist. A 88-year-old female patient of an unknown race received PREVNAR 13, (NDC number: 00005197102, UPC number: 30005197102, lot R45377, exp. date Dec2017) via intramuscular route at 0.5ml single dose for immunization on 12Nov2016. Relevant medical history included Chronic obstructive pulmonary disease and Hypothyroidism, ongoing. Concomitant medication included levothyroxine for hypothyroidism at 50 mg, 1x/day. On 13Nov2016 the patient experienced mild fever, redness and swelling at the vaccination site. The outcome was reported as not recovered. The patient has not taken any treatment.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Warmth, tenderness, erythema 10cm around Flu injection site with 2-3 hrs of injection.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram normal, Head injury, Seizure, Syncope
Clinical narrative: Fainted shortly after receiving flu vaccine.  Hit head on concrete floor, causing seizure.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Received injection and little or no pain at time of injection.  Later in the evening arm started hurting from left shoulder to elbow, hurt to life arm, next day was better.  Next few days it felt like getting better, but then last Wed Nov 9, it was so sore that it awakened her if she moved wrong.  On Thursday it hurt to cross over to right to put deodorant on , put bran off and on , put shirt off and on.  This was same Nov 9-13.  Now this week is better, just achy. Aleve helps.
Age: 60.0
Sex: F
Vaccine: FLUC4, PPV, TDAP, VARZOS
Symptoms: Contusion, Induration, Mass
Clinical narrative: After subcutaneous administration of ZOSTAVAX, patient developed hard lump about the size of a ping pong ball.  There was also slight bruising in the area.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Eye pruritus, Eye swelling, Lacrimation increased, Pharyngeal oedema
Clinical narrative: SWELLING, ITCHING AND WATERING ON EYES, SWELLING ON THROAT.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dizziness, Dyspnoea, Electrocardiogram, Heart rate increased
Clinical narrative: DIFFICULTY BREATHING, FAST HEARTBEAT, DIZZINESS, WEAKNESS, HEARTBEAT GOT PROGRESSIVELY FASTER ALONG WITH THE DIFFICULTY TO BREATHE, BECAME WEAKER. WENT TO EMERGENCY ROOM WHERE I WAS TREATED AND SEEN BY A PHYSICIAN.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: X-ray
Clinical narrative: DIFFICULTY BREATHING, FAST HEARTBEAT, DIZZINESS, WEAKNESS, HEARTBEAT GOT PROGRESSIVELY FASTER ALONG WITH THE DIFFICULTY TO BREATHE, BECAME WEAKER. WENT TO EMERGENCY ROOM WHERE I WAS TREATED AND SEEN BY A PHYSICIAN.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Ear infection, Inflammation, Injection site pain, Pain, Weight bearing difficulty
Clinical narrative: Normal shot soreness started that afternoon and lasted for 3 days.  Then around Nov 1 or 2, 2016 started having pain with moving left arm when taking off shirt or putting on seat belt and  would have shooting pain with this activity. Couldn't bear weight on left arm when lying down.
Age: 66.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Blood test, Hypersensitivity, Pain, Pyrexia
Clinical narrative: Went to Emergency Room. Arm throbbing, sore, fever, pain, advised that I had allergic reaction. Would have to wait out, take benadryl. next day went to Dr that said allergic, take benadryl, could take 2-4 weeks to subside.
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Herpes zoster, Lymphadenopathy, Pain
Clinical narrative: Shingles, pain, swollen axial lymph nodes on side of the shingles rash.
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: The patient called and said the injected site is swollen (about 4 inches in diameter), redness, and itchy. No other complication. She applied ice but did not help. Adviced patient to take Benadryl and see her doctor as soon as possible to have it check out.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, itching, hot to touch, inflamed, swollen at injection site.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Eye pruritus, Hyperhidrosis, Lacrimation increased, Nasal congestion, Pain
Clinical narrative: Itchy eyes, watery eyes, nasal congestion, area under tongue swollen, chills, body aches, sweats. All resolved by 5:00 AM.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Swollen tongue
Clinical narrative: Itchy eyes, watery eyes, nasal congestion, area under tongue swollen, chills, body aches, sweats. All resolved by 5:00 AM.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Patient had been monitoring injection site after administration of Zostavax and had redness, swelling, and tenderness.  Four days after vaccination she noticed a vesicle, pock-like lesion about 1.5 inches below the injection site.  She came into the pharmacy to show us and it appears that it may be a localized shingles/chickenpox-like lesion or rash, which the potential for was discussed with the patient before vaccination.  I advised her to cover the area as a precaution.  She was interested in having the adverse event reported for the purpose of data collection.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Patient had been monitoring injection site after administration of Zostavax and had redness, swelling, and tenderness.  Four days after vaccination she noticed a vesicle, pock-like lesion about 1.5 inches below the injection site.  She came into the pharmacy to show us and it appears that it may be a localized shingles/chickenpox-like lesion or rash, which the potential for was discussed with the patient before vaccination.  I advised her to cover the area as a precaution.  She was interested in having the adverse event reported for the purpose of data collection.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: The day of the vaccination the patient called and told me her arm was very sore.  I called her later in the day to see how her arm was feeling and she told me better.  She came back today (11/16/16) to let me know her arm continued to be sore and she was having difficulty moving it so she was going to physical therapy and it was improving.  She did not think it needed to be reported but I told her all adverse vaccine reactions should be reported but she wanted to let me know she had rotator cuff surgery in that arm and she thinks that might be why she had the reaction so she suggests giving the vaccine in the non operated on arm.