chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Parvovirus B19 test negative, Red blood cell sedimentation rate increased, Rheumatoid arthritis, Rheumatoid factor positive
Clinical narrative: Initial case was retrieved from a search of the scientific literature on 10 September 2012. The following is verbatim from the article: "A 33-year-old female with no significant past medical history was referred to the rheumatology clinic in May 2010 by her primary care physician for having pain and swelling in multiple joints since November 2009. Patient received a seasonal flu shot in October and a week later, she noted some joint pain and aches in hands, wrists, and knees, which resolved within a few days and patient became asymptomatic. A month later, she received H1N1 vaccine and a week after started experiencing joint pain, swelling, and stiffness in hand, wrist, elbow, shoulder, and knee joints. She also complained of significant morning stiffness that last for more than one hour. On physical examination she had bilateral synovitis in fourth and fifth metacarpophalangeal (MCP), second, and third proximal interphalangeal (PIP) joints, with prominent left ulnar styloid. She fulfilled most of the criteria for classification of RA based on College of Rheumatology (CR) guidelines. Laboratory findings initially included an erythrocyte sedimentation rate (ESR) of 24 mm/hr, rheumatoid factor (RF) of 26 IU/mL, C-reactive protein (CRP) of 1.3mg/dL, cyclic citrullinated peptide (CCP) IgG of 212. Her basic chemistry, liver function tests, hemoglobin, and complement levels were essentially within normal limits. Serological tests were positive for antinuclear antibody (ANA), RF, anticyclic citrullinated peptide (anti-CCP) and negative for SSA, SSB, hepatitis C virus, parvovirus B19 and being immunized for hepatitis B. Her radiological findings were negative for any joint effusion or destruction. On initial presentation to her PCP, she was given a 10-day course of prednisone 40mg daily, which partially helped with symptoms in the beginning with eventual relapse of symptoms. Later she was started on methotrexate 7.5 mg weekly along with a short duration (3 weeks) of low-dose prednisone with daily folic acid and calcium/vitamin D supplementation. During her follow-up visit about 2 months later, her disease activity score (DAS) were 4.83 and number of tender joints was 7 and number of swollen joints were 5, with significant improvement in morning stiffness which lasted for 5-10 minutes. However, her pain was controlled only while she was on steroid therapy for 3 weeks and had returned thereafter. Later she was switched to golimumab (TNF-a inhibitor) 50mg once monthly subcutaneously. Her methotrexate dose was also increased to 12.5mg weekly. At her third visit her symptoms were much improved and her ESR and CRP were also within normal limits. In conclusion, a causal relationship has not been confirmed between swine-flu vaccine and onset of RA, but there is a temporal connection between the two based on our case report." The patient's outcome was not reported. Documents held by sender: None.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Synovitis, X-ray normal
Clinical narrative: Initial case was retrieved from a search of the scientific literature on 10 September 2012. The following is verbatim from the article: "A 33-year-old female with no significant past medical history was referred to the rheumatology clinic in May 2010 by her primary care physician for having pain and swelling in multiple joints since November 2009. Patient received a seasonal flu shot in October and a week later, she noted some joint pain and aches in hands, wrists, and knees, which resolved within a few days and patient became asymptomatic. A month later, she received H1N1 vaccine and a week after started experiencing joint pain, swelling, and stiffness in hand, wrist, elbow, shoulder, and knee joints. She also complained of significant morning stiffness that last for more than one hour. On physical examination she had bilateral synovitis in fourth and fifth metacarpophalangeal (MCP), second, and third proximal interphalangeal (PIP) joints, with prominent left ulnar styloid. She fulfilled most of the criteria for classification of RA based on College of Rheumatology (CR) guidelines. Laboratory findings initially included an erythrocyte sedimentation rate (ESR) of 24 mm/hr, rheumatoid factor (RF) of 26 IU/mL, C-reactive protein (CRP) of 1.3mg/dL, cyclic citrullinated peptide (CCP) IgG of 212. Her basic chemistry, liver function tests, hemoglobin, and complement levels were essentially within normal limits. Serological tests were positive for antinuclear antibody (ANA), RF, anticyclic citrullinated peptide (anti-CCP) and negative for SSA, SSB, hepatitis C virus, parvovirus B19 and being immunized for hepatitis B. Her radiological findings were negative for any joint effusion or destruction. On initial presentation to her PCP, she was given a 10-day course of prednisone 40mg daily, which partially helped with symptoms in the beginning with eventual relapse of symptoms. Later she was started on methotrexate 7.5 mg weekly along with a short duration (3 weeks) of low-dose prednisone with daily folic acid and calcium/vitamin D supplementation. During her follow-up visit about 2 months later, her disease activity score (DAS) were 4.83 and number of tender joints was 7 and number of swollen joints were 5, with significant improvement in morning stiffness which lasted for 5-10 minutes. However, her pain was controlled only while she was on steroid therapy for 3 weeks and had returned thereafter. Later she was switched to golimumab (TNF-a inhibitor) 50mg once monthly subcutaneously. Her methotrexate dose was also increased to 12.5mg weekly. At her third visit her symptoms were much improved and her ESR and CRP were also within normal limits. In conclusion, a causal relationship has not been confirmed between swine-flu vaccine and onset of RA, but there is a temporal connection between the two based on our case report." The patient's outcome was not reported. Documents held by sender: None.
Age: 0.56
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis
Clinical narrative: Initial report received on 13 September 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in an 10 month old, female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) database. The subject's vaccine history included 3 doses of PENTACEL: lot C4081AA received on 06 December 2011, lot C4158AB received on 16 February 2012, and lot C4158AB received on 24 April 2012 (route and site of administration not reported). Approximately 4 months after the last dose, on 07 August 2012, she developed a cough. On 15 August 2012, she developed a paroxysmal cough without a whoop. She also experienced symptoms of apnea and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 14 August 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin for 5 days starting on 14 August 2012. The subject was not hospitalized. At the time of final contact on 06 September 2012, the subject's cough was still present. At that time, the duration of the cough was reported as 30 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.56
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Sleep disorder
Clinical narrative: Initial report received on 13 September 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in an 10 month old, female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) database. The subject's vaccine history included 3 doses of PENTACEL: lot C4081AA received on 06 December 2011, lot C4158AB received on 16 February 2012, and lot C4158AB received on 24 April 2012 (route and site of administration not reported). Approximately 4 months after the last dose, on 07 August 2012, she developed a cough. On 15 August 2012, she developed a paroxysmal cough without a whoop. She also experienced symptoms of apnea and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 14 August 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin for 5 days starting on 14 August 2012. The subject was not hospitalized. At the time of final contact on 06 September 2012, the subject's cough was still present. At that time, the duration of the cough was reported as 30 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.54
Sex: M
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Pertussis, Sleep disorder
Clinical narrative: Initial report received on 13 September 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a two year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received three doses of PENTACEL; lot number C3609AB received on 07 October 2010, lot number C33669AA received on 03 December 2010 and lot number C3334AA received on 28 April 2011 and a dose of TRIPEDIA lot number U3470DA on 09 February 2012 (routes and sites of administration not reported). The subject developed cough on 14 August 2012, approximately 6 months after the last dose. On an unspecified date, the subject developed a paroxysmal cough without a whoop. The subject also experienced sleep disturbance. It was unknown if a PCR test was conducted. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 30 August 2012 for five days. The subject was not hospitalized. At the time of final contact on 05 September 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 22 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: none.
Age: 1.53
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: Initial report received on 13 September 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a three year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received four doses of PENTACEL; lot number C3177AA received on 17 March 2009, lot number C3305AA received on 04 June 2009, lot number C3431AA received on 07 August 2009 and lot number C3590AA on 17 August 2010 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 11 June 2012, approximately 22 months after the last dose. On 18 June 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 03 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 03 July 2012 for five days. The subject was not hospitalized. At the time of final contact on 17 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 36 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: none.
Age: 1.53
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Pertussis, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 13 September 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a three year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received four doses of PENTACEL; lot number C3177AA received on 17 March 2009, lot number C3305AA received on 04 June 2009, lot number C3431AA received on 07 August 2009 and lot number C3590AA on 17 August 2010 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 11 June 2012, approximately 22 months after the last dose. On 18 June 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 03 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 03 July 2012 for five days. The subject was not hospitalized. At the time of final contact on 17 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 36 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain
Clinical narrative: 3 days after the vaccine she started having pain in one side of her face. It is very painful.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 13 September 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in an 2 year old, female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS). The subject's vaccine history included 3 doses of PENTACEL received on 11 June 2010, 23 August 2010, and 06 October 2010 (route, site of administration, and lot numbers were not reported). Approximately 20 months after the last dose, on 14 July 2012, she developed a cough and a day later she developed cold-like symptoms. On 19 July 2012, the child developed paroxysmal cough with a whoop. She also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 20 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin for 5 days starting on 19 July 2012. The subject was not hospitalized. At the time of final contact on 17 August 2012, the subject's cough was still present. At that time, the duration of the cough was reported as 34 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 13 September 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in an 2 year old, female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS). The subject's vaccine history included 3 doses of PENTACEL received on 11 June 2010, 23 August 2010, and 06 October 2010 (route, site of administration, and lot numbers were not reported). Approximately 20 months after the last dose, on 14 July 2012, she developed a cough and a day later she developed cold-like symptoms. On 19 July 2012, the child developed paroxysmal cough with a whoop. She also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 20 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin for 5 days starting on 19 July 2012. The subject was not hospitalized. At the time of final contact on 17 August 2012, the subject's cough was still present. At that time, the duration of the cough was reported as 34 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Eye pruritus, Ocular hyperaemia, Pruritus, Urticaria
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 14 September 2012. An 84-year-old female patient received a dose one intramuscular injection in the left deltoid of FLUZONE HIGH-DOSE, lot number U4494AA, on 10 September 2012. On 11 September 2012, the patient developed redness and severe itching over her neck, face, eyes, right arm, chest and pelvic area. The patient also had welts develop on the neck and across the side of the face. She saw her healthcare provider (HCP) and was given MEDROL pack. The patient had no illness at the time of vaccination and an allergy to penicillin and sulfa drugs. The patient had influenza vaccines in the past and never had any type of reaction. The patient received no other vaccinations within four weeks of FLUZONE. The patient's outcome was not recovered. Documents held by sender: None.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dysphagia, Eye swelling, Oropharyngeal pain, Swelling face
Clinical narrative: Initial report was received from a health care professional on 13 September 2012. A 53-year-old female patient had received FLUZONE INTRADERMAL 0.5 ml IM in the right deltoid (lot number UT4470AA) and within 4 hours experienced periorbital/face swelling, "couldn't swallow-tongue", and pain in chest and throat. The patient had a medical history of C-section (1992), appendectomy (age 7), Lasik (2001), and stereotactic biopsy ("5-06"). The patient had no concomitant medications. No further information was available at the time of the report. The patient outcome was recovered. Documents held by sender: None.
Age: 78.0
Sex: F
Vaccine: FLUX
Symptoms: Blister, Chills, Dizziness, Eye infection, Eye pruritus
Clinical narrative: Second day following flu shot, felt very tired, painful sore throat accompanied by chills and pain down right side of neck took 500 mg TYLENOL and applied ice pack - results little relief. 3rd day awakened with blistered rash on right side of forehead into scalp, swollen right eye, very itchy infected eye. This letter is written to further explain the symptoms of my illness complication as related to the influenza vaccination. Two days following the vaccination a painful blistered rash appeared on the right side of my forehead along the side of the face and about 3/4 way into my scalp. The rash also covered the right eyelid with severe swelling, causing extensive medical treatment because my eye became infected. I received my treatment from provider, necessitating four or more visits, and the administration of costly prescription drugs for the eye. Additionally I also suffered severe dizziness and throwing up, and on 10/16/11 required emergency room treatment at hospital. As indicated on my attached VAERS reporting form my primary care physician diagnosed and treated the shingles virus. I am reporting this information in hopes that it will be valuable to CDC & FDA in evaluating public health safety and prevention. I have kept record of all doctor visits and diagnosis relating to the incident.
Age: 78.0
Sex: F
Vaccine: FLUX
Symptoms: Eye swelling, Eyelid oedema, Fatigue, Neck pain, Oropharyngeal pain
Clinical narrative: Second day following flu shot, felt very tired, painful sore throat accompanied by chills and pain down right side of neck took 500 mg TYLENOL and applied ice pack - results little relief. 3rd day awakened with blistered rash on right side of forehead into scalp, swollen right eye, very itchy infected eye. This letter is written to further explain the symptoms of my illness complication as related to the influenza vaccination. Two days following the vaccination a painful blistered rash appeared on the right side of my forehead along the side of the face and about 3/4 way into my scalp. The rash also covered the right eyelid with severe swelling, causing extensive medical treatment because my eye became infected. I received my treatment from provider, necessitating four or more visits, and the administration of costly prescription drugs for the eye. Additionally I also suffered severe dizziness and throwing up, and on 10/16/11 required emergency room treatment at hospital. As indicated on my attached VAERS reporting form my primary care physician diagnosed and treated the shingles virus. I am reporting this information in hopes that it will be valuable to CDC & FDA in evaluating public health safety and prevention. I have kept record of all doctor visits and diagnosis relating to the incident.
Age: 78.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Rash, Varicella virus test, Vomiting
Clinical narrative: Second day following flu shot, felt very tired, painful sore throat accompanied by chills and pain down right side of neck took 500 mg TYLENOL and applied ice pack - results little relief. 3rd day awakened with blistered rash on right side of forehead into scalp, swollen right eye, very itchy infected eye. This letter is written to further explain the symptoms of my illness complication as related to the influenza vaccination. Two days following the vaccination a painful blistered rash appeared on the right side of my forehead along the side of the face and about 3/4 way into my scalp. The rash also covered the right eyelid with severe swelling, causing extensive medical treatment because my eye became infected. I received my treatment from provider, necessitating four or more visits, and the administration of costly prescription drugs for the eye. Additionally I also suffered severe dizziness and throwing up, and on 10/16/11 required emergency room treatment at hospital. As indicated on my attached VAERS reporting form my primary care physician diagnosed and treated the shingles virus. I am reporting this information in hopes that it will be valuable to CDC & FDA in evaluating public health safety and prevention. I have kept record of all doctor visits and diagnosis relating to the incident.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Induration, Local reaction, Myalgia, Skin warm, Tenderness
Clinical narrative: Lower extremity myalgia local reaction & induration 2cm/2cm marked tenderness, skin warm.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Dyspnoea, Erythema, Hypersensitivity
Clinical narrative: Allergic reaction, difficulty breathing, tightness in airways, redness, coughing, heart pounding, eyes red. Itchiness, burning where shot administered.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site pruritus, Ocular hyperaemia, Palpitations
Clinical narrative: Allergic reaction, difficulty breathing, tightness in airways, redness, coughing, heart pounding, eyes red. Itchiness, burning where shot administered.
Age: 1.04
Sex: M
Vaccine: HEP, HIBV, MMR
Symptoms: Decreased appetite, Irritability, Pyrexia
Clinical narrative: Imms on Fri, fussy, fever onset & Sat, continues til 9/18/12 when called office. S/S fever 101, fussy, loss of appetite. Advised MOTRIN & monitor to call back 9/19/12. Mom called back. Fever resolved.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: Swelling at injection site immediately after injection, decreased later that evening per mother, no other symptoms.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Arm swollen, red, hot to touch. no systemic fever. Treatment ibuprofen PRN.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Patient complained of itching at injection site after administration and then woke up with a circular rash around injection site on Sunday 9/23/12. Advised pt. to take BENADRYL.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Local reaction
Clinical narrative: Positive local reaction - redness over length of thigh.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haematoma, Injection site swelling, Injection site vesicles
Clinical narrative: Swelling, bruising, blistering at site of flu vaccine injection.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Lacrimation increased, Lip swelling, Ocular hyperaemia, Throat irritation
Clinical narrative: Tightness and discomfort in chest, tightness and irritation in her throat and her lips began to swell. Eyes extremely red and watery.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Tightness and discomfort in chest, tightness and irritation in her throat and her lips began to swell. Eyes extremely red and watery.
Age: 79.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Local reaction, Skin warm, Swelling
Clinical narrative: Local redness and swelling. Skin warm to touch. Starting 2 days after injection.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Oedema peripheral, Rash erythematous
Clinical narrative: Hands/feet swollen fine red rash over entire body.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Oedema peripheral, Rash erythematous, Rash generalised
Clinical narrative: Feet/hands swollen, fine red rash over entire body.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness, pain, swelling.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Culture stool, Diarrhoea, Haematochezia, Mucous stools, Occult blood
Clinical narrative: Loose stools bloody mucousy stools.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Urinary system X-ray
Clinical narrative: Loose stools bloody mucousy stools.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Burning sensation, Erythema, Pain, Pruritus
Clinical narrative: Lt. arm subcutaneous inj. varicella large reddened area, burns, itches, painful area increased 1 cm to total circumference of 10.5cm.
Age: 59.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site warmth, Rash erythematous
Clinical narrative: Elevated, red, warm rash at injection site. Don't know if related but also red patchy site at nape of neck.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Breast swelling, Erythema, Oedema peripheral, Skin warm
Clinical narrative: Entire arm (wrist to shoulder) red, hot, & swollen; Pt stated red, & swollen area had moved into underarm & breast tissue as well.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea
Clinical narrative: 3 episodes of diarrhea the day after vaccine.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Paraesthesia
Clinical narrative: 9-19-12 prior to giving HPV #3 child & grandmother mentioned 2 days after receiving dose #2 of HPV child was dizzy & had tingling sensation of both legs which last 4 days. HPV #3 was not given.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Miller Fisher syndrome
Clinical narrative: Guillain-Barre with Miller-Fisher variant.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Pt. described feeling a numbness, tingling, and occasional pain in the left arm - beginning a few weeks after flu shot was given.
Age: 3.0
Sex: F
Vaccine: UNK
Symptoms: Contusion, Haemorrhage, Idiopathic thrombocytopenic purpura, Petechiae, Platelet count decreased
Clinical narrative: Has developed ITP. Symptoms include bruising, petechiae, bleeding that is hard to control. Future treatment includes corticosteroids/IV/Ig/possible spleen removal.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Irritability, Myosclerosis, Screaming
Clinical narrative: Fussiness & screaming after immunizations on 9/18/12 muscle felt knotted/hard, TYLENOL & warm bath did not help. Fell asleep 4:54 pm.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea, Pain, Pyrexia, Rash, Rash erythematous
Clinical narrative: Nausea, fever & body aches within 24 hours also bright red rash across chest & bilateral axilla neck & abdomen.
Age: 12.0
Sex: M
Vaccine: FLU3, HEPA, HPV4, MNQ, TDAP
Symptoms: Dizziness, Immediate post-injection reaction, Lethargy, Pyrexia
Clinical narrative: Felt dizzy immediately after vaccines and resolved within hours. Next day was lethargic / low grade fever 2 days after vaccines vomit x 1.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: 11PM - pt said she threw up 3 times.
Age: 10.0
Sex: M
Vaccine: FLUN3, HEPA
Symptoms: Injection site rash
Clinical narrative: Rash around injection site.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Hyperhidrosis, Nausea
Clinical narrative: On 09/13/12 patient (pt.) reported experiencing nausea & sweating (all over "wringing wet") within 8-9 hrs. & lasting 4-5 hrs after receipt of Hepatitis B #1 dose of vaccine. No additional vaccinations were received on 07-13-12. Pt. did not seek medical care.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure increased, Pruritus, Urticaria
Clinical narrative: 16 1/2 hours after immunization developed hives on stomach and back. 26 hours post-immunization hives on whole body. Went to hospital ER. BP increased. IV BENADRYL and prednisone give. Sent home with Rx for oral BENADRYL and prednisone. Returned to ER on Sunday 9/23 for severe itching. IV prednisone given and sent home.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Pt experienced numbness/tingling down (L) arm following injection - referred to ER.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthropod sting, Condition aggravated, Inflammation
Clinical narrative: 2 wks prior to flu HD & pneumo, patient was stung multiple times on (L) upper arm by a yellow jacket wasp. After immunization the areas around the stings became very inflamed.
Age: 64.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: Pain - Left upper arm at site of injection, Patient subjectively felt weakness to left hand, reported to physician & had physical exam on 9-19-2012. Symptoms occurred daily since 6-27-2012 injection.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Pain, Pyrexia
Clinical narrative: -> Redness & swelling at the site of injection. -> Fever. -> Body aches. -> Lump at the site of injection.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, FLUN3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 7.5 cm erythematous, indurated area with soft margin and central clearing at site (L) - thigh.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Raised, red, hard (knot like) area the size of a dime that still appears when the vaccine was given by a pharmajet device on the right upper deltoid.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Loss of consciousness, Posture abnormal
Clinical narrative: Right after I finished the shot, pt's head dropped down & had approximately 10 seconds of seizures. But she regained consciousness right away. She didn't remember what happened & was scared. After 10 mins rest we helped her get home & she slept.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: Pt had vaccine on Friday 9/21/12/. On Sat 9/22 at same she noticed redness swelling & discomfort at side of injection on Sun 9/23 she started with headache at 6 am.
Age: 47.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain, Insomnia, Pain in extremity, Paraesthesia
Clinical narrative: Pt reports after one week below injection site (L) deltoid that radiates down to index finger & middle finger is painful and tingling and this makes it difficult for him to sleep.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Joint swelling, Pain in extremity, Pruritus
Clinical narrative: (R) forearm pain 9/18/2012. (R) Wrist swelling and numbness. Itching.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Erythema, Induration, Local swelling, Skin warm
Clinical narrative: Deep pain radiating to armpit. Local swelling/hard & hot to touch & red.
Age: 1.03
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Papule, Petechiae, Rash, Vasculitis
Clinical narrative: Vasculitis. Rash on face, trunk, extremities. Palpable papules with some petechiae on face 8 days after MMR.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Induration, Injection site cellulitis
Clinical narrative: Cellulitis diagnosed at the site of injection 3 day post vaccination. Area of induration & erythema 7 x 7 mm treated with AUGMENTIN.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Blood pressure increased, Condition aggravated, Personality change
Clinical narrative: Seen at ER 8/27/2012 due to hand laceration received Tdap. Days following had increased BP, and change in personality. Last tetanus x 8-10 yr ago without incident states arm did not "get sore" like all other times.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site atrophy
Clinical narrative: None - Hep A #2 given 7/12/12. On 9/19/12 client mom consulted NP who returned to HD. Denies any prior concerns other than "dent in leg". No other symptoms.
Age: 18.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site papule, Injection site warmth
Clinical narrative: Pt noticed erythematous papules around the injection site of the PNEUMOVAX on 9/14/12. The next day the area became warm and red.
Age: 11.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Back pain, Dizziness, Headache, Nausea, Vomiting
Clinical narrative: Received influenza and Hep A vaccine 9/12/2012. Client was fine that day. 9/14/2012 900 pm complained of back pain severe - took TYLENOL - better L - eased up - still hurt Sat morning 9/15/2012 - complained of backache upper (L) quadrant started feeling dizzy 100 pm vomited 9/17 and 9/18 headache nausea and dizziness comes and goes.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Eyelid oedema
Clinical narrative: Took influenza at 130pm. At 6:00pm (R) eye began to itch & lower lid with lg amt of swelling. Took BENADRYL & 30 min later took another BENADRYL. Applied ice & 2 hrs swelling decreased some. BENADRYL repeated at 2am. Swelling cont to decrease next day. Eats eggs routinely.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis bilateral deltoids. - KEFLEX 500 mg TIDx10d. - BENADRYL 2 tsp TID prn x 1 w. - Cool compress.
Age: 51.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Two days after pt. received ZOSTAVAX vaccine, she came in and had large red circle at injection site and it was warm to touch.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Arthralgia, Blood test, Dyskinesia, Full blood count normal
Clinical narrative: 09/14/12 Fri am stiff all over - noon - pain increased, all joints and to jaw, bed bound - rocking, rolling movement to help pain lessen. ER Fri night 2pm, test, blood work, morphine, TORADOL PHENERGAN. Home with VICODIN, muscle relaxant ROTAXIN to home q 4 hours x 2 days Sat, Sun. Monday am feel better back to work.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Metabolic function test normal, Musculoskeletal stiffness, Pain in jaw, Urine analysis normal
Clinical narrative: 09/14/12 Fri am stiff all over - noon - pain increased, all joints and to jaw, bed bound - rocking, rolling movement to help pain lessen. ER Fri night 2pm, test, blood work, morphine, TORADOL PHENERGAN. Home with VICODIN, muscle relaxant ROTAXIN to home q 4 hours x 2 days Sat, Sun. Monday am feel better back to work.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Two days after injection was given, a red welt measuring approx 4 inches long & 2 inches wide appeared on my upper arm where the injection was given.
Age: 79.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Secondary transmission
Clinical narrative: Patient received zoster shingles on 9/07/2012. Wife was ill on 9/15 and seen and treated at Urgent Care, later seen by Dr. on 9/28/2012 who diagnosed it as disseminated shingles/chicken pox.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Hemiplegia, Pain in extremity
Clinical narrative: Per human resources, pharmacy, patient had pain in left arm 1 week after vaccine. Then recently went to MD and now paralysis left side of body. Per representative, patient in hospital on prednisone then physical therapy in future.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Headache, body ache, fever (101.6), swelling and pain at site.  Hardness at site and intense itching, also red and hot about 3" diameter around site injection.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Headache, body ache, fever (101.6), swelling and pain at site.  Hardness at site and intense itching, also red and hot about 3" diameter around site injection.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Muscular weakness, Neuralgia, Pain
Clinical narrative: Left humoral, radial ulnar nerve pain/weakness for last 11 days. Loss of strength in left arm. At times extreme pain on rotation.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site discolouration, Injection site induration, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: PAIN, SWELLING, EGG-SHAPED HARD KNOT AT LEFT DELTOID INJECTION SITE WITH WHITE CENTER; FEVER OF 101 TO 103 FOR 24 HOURS.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Mobility decreased, Pain, Paraesthesia
Clinical narrative: My hand got numb and tingled immediately. Within 15 minutes, I could not move my arm and was in severe pain. Three days later, I am still in pain. I will be going to my PCP on Wednesday.
Age: 40.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Pneumonia
Clinical narrative: Pt got pneumonia after 2 days after getting shot and could not move the arm for about 3 days. Had to go to ER & was at hospital for 1 day. He is treated with antibiotics.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Concussion, Dizziness, Laceration, Syncope
Clinical narrative: Felt faint several minutes after flu vaccine was received, attempted to return to the clinic, collapsed in hallway and sustained laceration to chin and mild concussion.
Age: 1.17
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Decreased activity, Decreased appetite, Diarrhoea, Faeces pale, Irritability
Clinical narrative: FIRST VOMITING, THEN PALE YELLOW LOOSE STOOLS, LOSS OF APPETITIE, FUSSINESS, LESS ACTIVE. MOTHER PLANS TO TAKE SON TO DOCTOR.
Age: 1.17
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Vomiting
Clinical narrative: FIRST VOMITING, THEN PALE YELLOW LOOSE STOOLS, LOSS OF APPETITIE, FUSSINESS, LESS ACTIVE. MOTHER PLANS TO TAKE SON TO DOCTOR.
Age: 88.0
Sex: M
Vaccine: PNC10
Symptoms: Cough, Erythema, Nodule, Swelling
Clinical narrative: Red, swollen "baseball size knot" as stated per caregiver. Physician notified-ice applied. 9/24/12-patient is going to see physician-swelling gone-but patient has had a cough since the vaccination
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Back pain, Chills, Dizziness, Fatigue, Musculoskeletal pain
Clinical narrative: Fatigue, neck, shoulder and back pain, chills,l ightheadedness, muscle soreness and stiffness.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Musculoskeletal stiffness, Myalgia, Neck pain
Clinical narrative: Fatigue, neck, shoulder and back pain, chills,l ightheadedness, muscle soreness and stiffness.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Syncope after receiving flushot X2 pt was fasting for labs he got the flu shot prior to completing his labs.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Spinal pain
Clinical narrative: Later in the day after receiving the vaccine developed burning pain along entire spine followed by generalized muscle pain in back. Self treated with Robaxin and Motrin. Pain persisted for approximately 18-24 hrs.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Dysuria, Fatigue, Injection site pruritus, Pain
Clinical narrative: Fatigue, body ache and fever begin to set in. High discomfort in passing urine. Fever peaked at 11:30 pm at 102.1 and began to subside at at 1:30 AM. Extreme joint pain continued through most of the night, but painful urination subsided around 1:30 AM. Generally achey for the day of 09/19/2012. Temperature returns to normal by 3:00 PM on the 19th.  Primary Physician runs viral test but test result is negative. Injection site is still mildly itchy on this date 12/24/2012.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Viral test negative
Clinical narrative: Fatigue, body ache and fever begin to set in. High discomfort in passing urine. Fever peaked at 11:30 pm at 102.1 and began to subside at at 1:30 AM. Extreme joint pain continued through most of the night, but painful urination subsided around 1:30 AM. Generally achey for the day of 09/19/2012. Temperature returns to normal by 3:00 PM on the 19th.  Primary Physician runs viral test but test result is negative. Injection site is still mildly itchy on this date 12/24/2012.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Conjunctivitis, Eye discharge, Ocular hyperaemia
Clinical narrative: Bilateral conjunctivitis with severe occular redness and green discharge.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Cold sweat, Dizziness, Hyperhidrosis, Hypotension
Clinical narrative: Approx 5 mins after receiving flu shot, pt found sitting slumped and mumbling in chair. Patient was conscious but not responding to questions. Rph asked staff member to call 911 immediately and 2nd rph prepared epipen for administration. rph returned to patient who (approx ~10 seconds after being found) was responsive to questioning and coherent. Patient claimed to have upset stomach and dizzy/had to use bathroom. patient was sweating and clammy. Rph engaged patient in conversation until paramedics arrived. Paramedics said blood pressure was low at sitting and standing position and determined patient needed to go to er for further evaluation. (Epipen not given to patient at store).
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Unresponsive to stimuli
Clinical narrative: Approx 5 mins after receiving flu shot, pt found sitting slumped and mumbling in chair. Patient was conscious but not responding to questions. Rph asked staff member to call 911 immediately and 2nd rph prepared epipen for administration. rph returned to patient who (approx ~10 seconds after being found) was responsive to questioning and coherent. Patient claimed to have upset stomach and dizzy/had to use bathroom. patient was sweating and clammy. Rph engaged patient in conversation until paramedics arrived. Paramedics said blood pressure was low at sitting and standing position and determined patient needed to go to er for further evaluation. (Epipen not given to patient at store).
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Oedema, Pyrexia, Tenderness
Clinical narrative: Erythema, edema, warmth, and tenderness. Pt reports tactile fever.
Age: 55.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness, Neck pain, Oedema peripheral
Clinical narrative: Pain at site, heaviness in left arm and hand, stiff and painfull neck on left side, swollen, warm to the touch, unable to rais left arm.
Age: 55.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Sensation of heaviness, Skin warm
Clinical narrative: Pain at site, heaviness in left arm and hand, stiff and painfull neck on left side, swollen, warm to the touch, unable to rais left arm.
Age: 55.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Neck pain, Pain in extremity, Sensation of heaviness
Clinical narrative: Pain at site, heaviness in left arm and hand, stiff and painfull neck on left side, swollen, warm to the touch, unable to rais left arm.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Headache, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Skin felt prickly approx 5 hours after vaccine, woke up at 2 am and had a rash around her mouth, nausea, fever, abdominal pain, and a headache, in the morning she noticed the injection site was red and swollen approx 3in in diameter.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Pyrexia, Rash
Clinical narrative: Skin felt prickly approx 5 hours after vaccine, woke up at 2 am and had a rash around her mouth, nausea, fever, abdominal pain, and a headache, in the morning she noticed the injection site was red and swollen approx 3in in diameter.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dizziness, Fatigue, Feeling cold, Formication
Clinical narrative: Crawly skin, painful skin, blurry vision, dizzy, fell asleep until midnight, awoke with clothing hurting skin by touching it, cold chills, headache, nausea, took Advil with no result, took Bayer, still no result, slept until 10am, dizzy and tired on 9/22.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Nausea, Pain of skin, Vision blurred
Clinical narrative: Crawly skin, painful skin, blurry vision, dizzy, fell asleep until midnight, awoke with clothing hurting skin by touching it, cold chills, headache, nausea, took Advil with no result, took Bayer, still no result, slept until 10am, dizzy and tired on 9/22.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site urticaria
Clinical narrative: Bump/ hive at varicella injection site size of a penny with redness around it.
Age: 35.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: 9/20/12 I had a small red swollen area around injection site. 9/20/12-9/21/12 In the middle of the night (9/20) I woke up with fever/chills/leg aches and they continued till late in the evening of the 21st. 9/21/12 AM woke up with a larger red swollen area at injection site. 9/22/12 Fever/chills/aches had resolved but went to the ER around noon because red swollen area had grown again (they measured it at 13mmx13mm)- they prescribed me Keflex 500mg 1 cap q6h #20, Zyrtec 10mg 1 tab daily x15d, Lortab 5-500 1-2 tabs q6h prn pain #10 9/23/12 Arm (redness/swelling) grew overnight but only in one direction, towards my elbow. Continued meds. 9/24/12 Went in to my Family Medical Clinic for f/u. Arm grew again last night (9/23) and they measured the redness on my arm to be 19mmx15mm. They changed my treatment to D/C Keflex and begin Septra DS 1 tab bid x10d, D/C Zyrtec and begin Diphenhydramine 25mg 1 cap q6h prn itching, continue Lortab and IBU prn, and a new med Ranitidine 150mg bid x10d I follow up on 9/25/12 to see if new regimen is bringing the redness and swelling down.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Malaise, Pain in extremity, Tremor
Clinical narrative: Chilled, shaking uncontrollably. EMT's called. Pt was not transported. Felt very ill, both arms were sore.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Chills, Myalgia, Pyrexia
Clinical narrative: Severe chills, fever, severe arm and leg muscle/bone ache.
Age: 13.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Abscess sterile, Erythema, Induration, Injection site pain, Injection site swelling
Clinical narrative: Awoke 9/18/12 in AM with very painful, swollen, painful to touch (L) deltoid. Exam on 9/19/12 showed localized erythema induration & tenderness to 2 1/2 inches. Diagnosed as sterile abscess vaccine reaction. Treated with AUGMENTIN BID x 7 days.
Age: 13.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Tenderness, Vaccination complication
Clinical narrative: Awoke 9/18/12 in AM with very painful, swollen, painful to touch (L) deltoid. Exam on 9/19/12 showed localized erythema induration & tenderness to 2 1/2 inches. Diagnosed as sterile abscess vaccine reaction. Treated with AUGMENTIN BID x 7 days.