chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Nausea, Nervousness, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Pallor
Clinical narrative: This case was received on 13 July 2012 via a third party query tool search on the VAERS database, under reference number 453198. A 34-year-old male patient with no current illnesses, occasional use of creatinine and increased caffeine intake received the following vaccination on 05 April 2012: ACAM2000 (lot number VV04003A). The patient had history of irregular heart beat in 2005, negative cardiac work up due to increased caffeine intake, and per the patient, family history of mother who had very unhealthy lifestyle that died of cardiac causes at age 55. Four days post inoculation, the patient developed symptomatic ventricular tachycardia that was converted to NSR (normal sinus rhythm) with IV (intravenous) amiodarone. ECHO (echocardiogram) to rule out MI (myocardial infarction) revealed 45% EF (ejection fraction) that was consistent with myocarditis. ESR (erythrocyte sedimentation rate) and CRP (C-reactive protein) were pending. The event was considered life threatening. Hospitalization was reported. The patient recovered. Documents held by sender: None.
Age: 34.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Palpitations, Parvovirus B19 test negative, Protein total normal, Pyrexia, Red blood cell sedimentation rate normal
Clinical narrative: This case was received on 13 July 2012 via a third party query tool search on the VAERS database, under reference number 453198. A 34-year-old male patient with no current illnesses, occasional use of creatinine and increased caffeine intake received the following vaccination on 05 April 2012: ACAM2000 (lot number VV04003A). The patient had history of irregular heart beat in 2005, negative cardiac work up due to increased caffeine intake, and per the patient, family history of mother who had very unhealthy lifestyle that died of cardiac causes at age 55. Four days post inoculation, the patient developed symptomatic ventricular tachycardia that was converted to NSR (normal sinus rhythm) with IV (intravenous) amiodarone. ECHO (echocardiogram) to rule out MI (myocardial infarction) revealed 45% EF (ejection fraction) that was consistent with myocarditis. ESR (erythrocyte sedimentation rate) and CRP (C-reactive protein) were pending. The event was considered life threatening. Hospitalization was reported. The patient recovered. Documents held by sender: None.
Age: 34.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Thyroxine free normal, Troponin I increased, Troponin increased, Ventricular tachycardia, Vomiting
Clinical narrative: This case was received on 13 July 2012 via a third party query tool search on the VAERS database, under reference number 453198. A 34-year-old male patient with no current illnesses, occasional use of creatinine and increased caffeine intake received the following vaccination on 05 April 2012: ACAM2000 (lot number VV04003A). The patient had history of irregular heart beat in 2005, negative cardiac work up due to increased caffeine intake, and per the patient, family history of mother who had very unhealthy lifestyle that died of cardiac causes at age 55. Four days post inoculation, the patient developed symptomatic ventricular tachycardia that was converted to NSR (normal sinus rhythm) with IV (intravenous) amiodarone. ECHO (echocardiogram) to rule out MI (myocardial infarction) revealed 45% EF (ejection fraction) that was consistent with myocarditis. ESR (erythrocyte sedimentation rate) and CRP (C-reactive protein) were pending. The event was considered life threatening. Hospitalization was reported. The patient recovered. Documents held by sender: None.
Age: 1.07
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Confirmed varicella - 9/11/12. Multiple pox over back, chest, thighs, groin, buttocks.
Sex: M
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Optic neuritis
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a male patient of unknown age. On an unknown date in October 2012 the patient was vaccinated with a dose of ZOSTAVAX (lot# not reported) dose and route not reported. Other suspect therapies included Influenza Virus Vaccine (manufacture unknown) (lot # not reported) dose and route not specified. The physician reported that the patient who received ZOSTAVAX who developed optic neuritis on an unknown date in October 2012. Treatment information was unspecified by the reporter. The outcome of the reported event was unknown. It was unspecified if the patient sought medical attention. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, VARCEL
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of arm swelling (injection site) in a 4-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included varicella virus vaccine (non-gsk) ;non-GSK manufacturer;unknown;unknown given on 13 November 2012. On 13 November 2012 the subject received a dose of KINRIX (.5 ml, unknown route, left arm). On 14 November 2012, 1 day after vaccination with KINRIX, the subject experienced arm swelling (injection site) and injection site infection. The subject "experienced swelling in the arm from the shoulder to the elbow" and "bacterial infection". The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with oral antibiotics.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, VARCEL
Symptoms: Bacterial infection, Injection site infection, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of arm swelling (injection site) in a 4-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included varicella virus vaccine (non-gsk) ;non-GSK manufacturer;unknown;unknown given on 13 November 2012. On 13 November 2012 the subject received a dose of KINRIX (.5 ml, unknown route, left arm). On 14 November 2012, 1 day after vaccination with KINRIX, the subject experienced arm swelling (injection site) and injection site infection. The subject "experienced swelling in the arm from the shoulder to the elbow" and "bacterial infection". The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with oral antibiotics.
Age: 53.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Measles post vaccine
Clinical narrative: Pt. had onset of fever, chills, malaise on 10/6/12. Rash started on face/neck on 10/8/12. Spread to arms, back, chest. Evaluated by PCP on 10/9/12. State lab results - (+) Measles IgM, IgG, and PCR. CBC confirmed PCR result. Could not complete genetic sequencing. Symptoms lasted at least 4 days. DX w/ vaccine related Measles. Mumps, Rubella negative.
Age: 53.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Chills, Laboratory test abnormal, Malaise, Measles antibody positive, Measles post vaccine
Clinical narrative: Pt. had onset of fever, chills, malaise on 10/6/12. Rash started on face/neck on 10/8/12. Spread to arms, back, chest. Evaluated by PCP on 10/9/12. State lab results - (+) Measles IgM, IgG, and PCR. CBC confirmed PCR result. Could not complete genetic sequencing. Symptoms lasted at least 4 days. DX w/ vaccine related Measles. Mumps, Rubella negative.
Age: 53.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Mumps antibody test negative, Polymerase chain reaction, Pyrexia, Rash generalised, Rubella antibody negative
Clinical narrative: Pt. had onset of fever, chills, malaise on 10/6/12. Rash started on face/neck on 10/8/12. Spread to arms, back, chest. Evaluated by PCP on 10/9/12. State lab results - (+) Measles IgM, IgG, and PCR. CBC confirmed PCR result. Could not complete genetic sequencing. Symptoms lasted at least 4 days. DX w/ vaccine related Measles. Mumps, Rubella negative.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Breast pain, Breast swelling, Breast tenderness, Erythema, Feeling hot
Clinical narrative: I was working from 07:00 - 19:00 that day and went over to employee health at 11:00 to get the flu shot. At approximately 16:00, I began to experience pain in both of my breasts, which I can only describe as being similar to the engorgement I felt on occasion when I was still breastfeeding my first child. I continued to experience the pain for the duration of my shift but was unable to remove myself  from my work duties to take a look at myself. I arrived home at 21:00 (both breasts still hurting), and found that both breasts were very reddened and swollen. The swelling was markedly increased from the gradual swelling that had been present since the early weeks of my pregnancy. Additionally, my breasts felt very warm and were tender to touch. I went to sleep and woke up to find a slight decrease in redness, but the warmth, swelling, pain, and tenderness remained. I worked again from 07:00 to 19:00, and was able to call my OB/GYN and seek advice. An office nurse spoke with my OB/GYN and said that she had never heard of this occurring in relation to a flu vaccine and recommended I take 25 mg of Benadryl. As I was working, I did not feel comfortable taking the dose at that time, but did take the recommended 25 mg once I arrived home at 21:00. Additionally that day, I took my concern back to employee health, where I spoke with two nurse practitioners who also said that they had not heard of such a reaction, but they gave me the Fluzone vaccine information booklet and recommended that I report the incident. After taking the Benadryl and going to sleep that night, I awoke the next morning to find a complete relief in all symptoms at that time. However, I am still experiencing occasional returns of redness (irregardless of wearing a bra or not) and an unusual swelling of both breasts and nipples. I did not experience the redness or swelling as I am currently during my previous pregnancy and breastfeeding experience with my daughter.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Maternal exposure during pregnancy, Nipple swelling
Clinical narrative: I was working from 07:00 - 19:00 that day and went over to employee health at 11:00 to get the flu shot. At approximately 16:00, I began to experience pain in both of my breasts, which I can only describe as being similar to the engorgement I felt on occasion when I was still breastfeeding my first child. I continued to experience the pain for the duration of my shift but was unable to remove myself  from my work duties to take a look at myself. I arrived home at 21:00 (both breasts still hurting), and found that both breasts were very reddened and swollen. The swelling was markedly increased from the gradual swelling that had been present since the early weeks of my pregnancy. Additionally, my breasts felt very warm and were tender to touch. I went to sleep and woke up to find a slight decrease in redness, but the warmth, swelling, pain, and tenderness remained. I worked again from 07:00 to 19:00, and was able to call my OB/GYN and seek advice. An office nurse spoke with my OB/GYN and said that she had never heard of this occurring in relation to a flu vaccine and recommended I take 25 mg of Benadryl. As I was working, I did not feel comfortable taking the dose at that time, but did take the recommended 25 mg once I arrived home at 21:00. Additionally that day, I took my concern back to employee health, where I spoke with two nurse practitioners who also said that they had not heard of such a reaction, but they gave me the Fluzone vaccine information booklet and recommended that I report the incident. After taking the Benadryl and going to sleep that night, I awoke the next morning to find a complete relief in all symptoms at that time. However, I am still experiencing occasional returns of redness (irregardless of wearing a bra or not) and an unusual swelling of both breasts and nipples. I did not experience the redness or swelling as I am currently during my previous pregnancy and breastfeeding experience with my daughter.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Nausea, Pain, Wheezing
Clinical narrative: Wheezing, aches, chills, dizziness, nausea.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Disorientation, Headache, Injection site pain, Injection site swelling
Clinical narrative: 102 fever; injection site pain and swelling of 3 inches by 3 inches; joint pain; headache; slight nausea and disorientation.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Nausea, Pyrexia
Clinical narrative: 102 fever; injection site pain and swelling of 3 inches by 3 inches; joint pain; headache; slight nausea and disorientation.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site erythema, Injection site oedema, Injection site pruritus
Clinical narrative: Left Deltoid with edema, erythema, itching; employee C/O arm with numbness.
Age: 0.3
Sex: M
Vaccine: IPV
Symptoms: Hypotonia, Somnolence, Unresponsive to stimuli
Clinical narrative: Initial report was received on 09 November 2012 from a consumer, who is also the patient's parent. A four month old male patient received an injection of IPOL (lot number reported as 944240, but to be confirmed) on an unspecified date. The patient's medical history and concomitant medications were not reported. After vaccination, "for 1 hour the patient was sleepy, didn't move limbs when flicked, limp then recovered". Laboratory tests were not reported. Details of treatment were not reported. The patient had also received an injection of HIB, manufacturer unknown, approximately a few weeks prior to IPOL vaccination on an unspecified date. Details of vaccination were not reported. The reporter declined to provide further details. The patient's outcome was reported as recovered. Documents held by sender: None.
Age: 1.53
Sex: F
Vaccine: DTAP
Symptoms: Pertussis
Clinical narrative: Initial report received from a consumer, who is also the patient's parent, on 08 November 2012 with follow-up information received from the patient's physician's office. The event was reported during the course of a vaccine brand usage survey being conducted by a national sampling organization on behalf of sanofi pasteur. A female child (age not reported) had received three doses of PENTACEL; lot number C3162BA received in June 2009, lot number C3224AA received in April 2009 and lot number C3228AA received in February 2009, and one dose of DAPTACEL, lot number C3358AA in July 2010. According to the patient's parent, on an unspecified date, the patient developed whooping cough and their physician stated that the episode of whooping cough could have been worse if she hadn't been vaccinated. Outcome was not reported. Additional information received from the patient's physician noted that the physician's facility had no record of pertussis diagnosis. No additional information was provided at the time of the report. Documents held by sender: None.
Age: 0.77
Sex: M
Vaccine: HEP
Symptoms: Dysphagia, Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Developed weakness on lower extremities then swallowing difficult 1 month after 3rd HepB vac. Dx to have Guillain Barre by med center.
Age: 61.0
Sex: M
Vaccine: DT, FLU3
Symptoms: Abasia, Guillain-Barre syndrome, Impaired work ability, Sensory loss, Walking aid user
Clinical narrative: Within 3 weeks I lost feeling in feet, arms, and hands. Lost 30-40#, could not walk (used a walker). I had Guillain Barre. I had to use a wheel chair (I now use a cane). I can no longer work.
Age: 61.0
Sex: M
Vaccine: DT, FLU3
Symptoms: Weight decreased, Wheelchair user
Clinical narrative: Within 3 weeks I lost feeling in feet, arms, and hands. Lost 30-40#, could not walk (used a walker). I had Guillain Barre. I had to use a wheel chair (I now use a cane). I can no longer work.
Age: 31.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Pyrexia, Sepsis
Clinical narrative: Patient states got both vaccines in same arm, 8 hours later he presented with fever which rose to 104 degrees by the next morning. He went to the hospital where he was diagnosed with cellulitis and sepsis & was kept for 4 days for treatment.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Pulmonary oedema, Pyrexia
Clinical narrative: A day after vaccine, felt feverish & tired. 36 hrs after hospitalized. Patient said fluid in her lungs could be pneumonia.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Dry eye, Dysarthria, Ear pain, Eyelid function disorder, Hypoaesthesia oral
Clinical narrative: Bell's Palsy. R/S, facial drooping eyebrow, lip mouth, right eyelid stays open not blinking. R/S Tongue, numbness. Taste buds lessen. Pain muscle inside jaw, R/S chin to ear. With slight earache. Speech slurred, hard to eat. Loss of weight. Eye dryness and tearing constant R/S. Started 10-6-12 and still ongoing, no change.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypogeusia, Lacrimation increased, Mastication disorder, Myalgia, VIIth nerve paralysis
Clinical narrative: Bell's Palsy. R/S, facial drooping eyebrow, lip mouth, right eyelid stays open not blinking. R/S Tongue, numbness. Taste buds lessen. Pain muscle inside jaw, R/S chin to ear. With slight earache. Speech slurred, hard to eat. Loss of weight. Eye dryness and tearing constant R/S. Started 10-6-12 and still ongoing, no change.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Weight decreased
Clinical narrative: Bell's Palsy. R/S, facial drooping eyebrow, lip mouth, right eyelid stays open not blinking. R/S Tongue, numbness. Taste buds lessen. Pain muscle inside jaw, R/S chin to ear. With slight earache. Speech slurred, hard to eat. Loss of weight. Eye dryness and tearing constant R/S. Started 10-6-12 and still ongoing, no change.
Age: 16.0
Sex: M
Vaccine: FLUN3, HPV4, MNQ, VARCEL
Symptoms: Blood creatine phosphokinase MB increased, Brain natriuretic peptide increased, Chest pain, Culture positive, Echocardiogram normal
Clinical narrative: Vomiting, fever, then chest pain -> documented acute myocarditis with increased CK (MB fxn), increased Troponin, increased BNP, marked ST elevation admission 2d after vaccine. Also with 2d increased T & HA after vaccine. No rash. USV infectious w/u being pursued feel enterovirus most likely. Nasal viral panel negative DFA for influenza & other resp viruses; CX positive.
Age: 16.0
Sex: M
Vaccine: FLUN3, HPV4, MNQ, VARCEL
Symptoms: Electrocardiogram ST segment elevation, Enterovirus infection, Headache, Influenza virus test negative, Mycoplasma test positive
Clinical narrative: Vomiting, fever, then chest pain -> documented acute myocarditis with increased CK (MB fxn), increased Troponin, increased BNP, marked ST elevation admission 2d after vaccine. Also with 2d increased T & HA after vaccine. No rash. USV infectious w/u being pursued feel enterovirus most likely. Nasal viral panel negative DFA for influenza & other resp viruses; CX positive.
Age: 16.0
Sex: M
Vaccine: FLUN3, HPV4, MNQ, VARCEL
Symptoms: Myocarditis, Parvovirus B19 test positive, Polymerase chain reaction, Pyrexia, Toxoplasma serology
Clinical narrative: Vomiting, fever, then chest pain -> documented acute myocarditis with increased CK (MB fxn), increased Troponin, increased BNP, marked ST elevation admission 2d after vaccine. Also with 2d increased T & HA after vaccine. No rash. USV infectious w/u being pursued feel enterovirus most likely. Nasal viral panel negative DFA for influenza & other resp viruses; CX positive.
Age: 16.0
Sex: M
Vaccine: FLUN3, HPV4, MNQ, VARCEL
Symptoms: Troponin increased, Viral test negative, Viral test positive, Vomiting
Clinical narrative: Vomiting, fever, then chest pain -> documented acute myocarditis with increased CK (MB fxn), increased Troponin, increased BNP, marked ST elevation admission 2d after vaccine. Also with 2d increased T & HA after vaccine. No rash. USV infectious w/u being pursued feel enterovirus most likely. Nasal viral panel negative DFA for influenza & other resp viruses; CX positive.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Erythema, Flushing, Throat tightness
Clinical narrative: Face, arms, trunk, legs - red, flushed - anaphylactic reaction - airway tight - used EPI-PEN - treated in ED.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Laboratory test, Lumbar puncture, Neuropathy peripheral, Pain
Clinical narrative: This spontaneous report was received from a 78-year-old female patient regarding herself with no drug reactions/allergies and no pertinent medical history. Concurrent conditions included high blood pressure. On 08-JAN-2010 the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot# not reported) under the skin (subcutaneously) in her left arm. Concomitant medications included blood pressure medicine (unspecified). Patient stated that a few months after she received ZOSTAVAX she was diagnosed with Guillain-Barre syndrome on 04-APR-2010. She experienced extreme stinging and pain in legs. As the pain worsened she was admitted to hospital on 25-JUL-2010 for five days. She stated she was prescribed oxycodone for about 18 months to treat the pain. The doctor in the emergency room felt it was life threatening. She still had neuropathy in both her feet and she said she had a "dropped foot" as well. She had seen several doctors and has had 30 weeks of physical therapy. Patient was given NEURONTIN and PERCOCET for the events. A lot of lab studies were performed including spinal tap. The patient sought medical attention for the events. The event neuropathy dropped foot did not resolve at the time of this report. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peroneal nerve palsy
Clinical narrative: This spontaneous report was received from a 78-year-old female patient regarding herself with no drug reactions/allergies and no pertinent medical history. Concurrent conditions included high blood pressure. On 08-JAN-2010 the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot# not reported) under the skin (subcutaneously) in her left arm. Concomitant medications included blood pressure medicine (unspecified). Patient stated that a few months after she received ZOSTAVAX she was diagnosed with Guillain-Barre syndrome on 04-APR-2010. She experienced extreme stinging and pain in legs. As the pain worsened she was admitted to hospital on 25-JUL-2010 for five days. She stated she was prescribed oxycodone for about 18 months to treat the pain. The doctor in the emergency room felt it was life threatening. She still had neuropathy in both her feet and she said she had a "dropped foot" as well. She had seen several doctors and has had 30 weeks of physical therapy. Patient was given NEURONTIN and PERCOCET for the events. A lot of lab studies were performed including spinal tap. The patient sought medical attention for the events. The event neuropathy dropped foot did not resolve at the time of this report. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Blood electrolytes, Chest X-ray, Chest pain, Computerised tomogram thorax, Dizziness
Clinical narrative: Nausea, low heart rate (40) high blood pressure, dizzy, chest pain.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Echocardiogram, Full blood count, Heart rate decreased, Hypertension, Nausea
Clinical narrative: Nausea, low heart rate (40) high blood pressure, dizzy, chest pain.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: 2 weeks after recieving vaccination has tremendous pain in arm (same as injection site) seeing doctor on 11/20/12.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Vomiting
Clinical narrative: On the day after the Flumist, patient had 5 hours of vomiting every hour.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLUN3, MMR, VARCEL
Symptoms: Epistaxis
Clinical narrative: When the Flumist was administered into left nostril his nose bleed and soaked one tissue and then quick bleeding.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ, TDAP
Symptoms: Herpes simplex, Pyrexia
Clinical narrative: Fever up to 105.7 for 5 days (starting 6-7 hours after injections), ended up diagnosed with primary HSV outbreak. Recieved influenza, Menactra and Tdap that day.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture negative, CSF culture negative, CSF white blood cell count increased, Convulsion, Culture urine negative
Clinical narrative: Mother noticed pt to have head turning to the left and rhythmic kicking movements @ 5:30 p.m. which were self resolved.  Throughout that night she had 2 more episodes consisting of arm raising, back arching, leg kicking and leftward gaze.  She was taken to her PCP on 11/16 found to be seizing, sent to local ED for stabilization of status epilepticus.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dyskinesia, Electroencephalogram abnormal, Gaze palsy, Hypoxic-ischaemic encephalopathy, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Mother noticed pt to have head turning to the left and rhythmic kicking movements @ 5:30 p.m. which were self resolved.  Throughout that night she had 2 more episodes consisting of arm raising, back arching, leg kicking and leftward gaze.  She was taken to her PCP on 11/16 found to be seizing, sent to local ED for stabilization of status epilepticus.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Opisthotonus, Posture abnormal, Red blood cells CSF positive, Status epilepticus
Clinical narrative: Mother noticed pt to have head turning to the left and rhythmic kicking movements @ 5:30 p.m. which were self resolved.  Throughout that night she had 2 more episodes consisting of arm raising, back arching, leg kicking and leftward gaze.  She was taken to her PCP on 11/16 found to be seizing, sent to local ED for stabilization of status epilepticus.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Confusional state, Dysarthria, Mental status changes
Clinical narrative: Altered mental status, confusion, slurred speech, temperature of 101.7.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Lacrimation increased, Urticaria
Clinical narrative: Within 1 hour after vaccine administration, eyes started swelling, eyes watery and whelps on throat.  Resolved by 11/11/12.  Administered Benadryl Liquid 2 doses 1 hour apart.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Induration, Pain, Pruritus
Clinical narrative: Redness, pain, itching, swelling, hard lump, warmth and bruising.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Swelling
Clinical narrative: Redness, pain, itching, swelling, hard lump, warmth and bruising.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Cellulitis, Erythema, Skin warm, Swelling
Clinical narrative: Awoke with redness, swelling in am, by later in day redness and swelling had grown to 2 inches in diameter, warm to touch. Seen in urgent care, given cephalexin for cellulitis.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Patient received the Afluria Flu Vaccine at noon on 11/06/12.  By 4:00 PM he had a rash with hives and a few whelps all over his body from his neck down.  The rash persisted for 2 weeks.  He noticed that it started to fade first on his arms, followed by his chest, and then his legs were the last to resolve.  He never had any itching or discomfort with the rash.  Patient was sent to the Occupational Health physician on 11/09/12.  The Physician attributed the rash to the Afluria flu vaccine. He received no treatment. The physician requested that the manufacturer be contacted to determine the components of the vaccine.  Patient will then need to take this information to his primary care physician.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Pain
Clinical narrative: Patient described hurting on opposite side of body from which vaccine was administered. He also complained of tightness in chest and shortness of breath for around 2 weeks. I was not notified of events until 11/20/2012.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Very sore left arm 9 days after vaccination.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Oedema peripheral, Paraesthesia, Sensory disturbance
Clinical narrative: Swollen feeling in arm, saw Dr. Doctor treated patient for muscle spasms in back.  On Nov 16, pt reports still do not have proper feeling in thumb and tingling off and on down arm.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dizziness, Dyspnoea, Feeling abnormal, Headache
Clinical narrative: Weak, shaky, feeling at base of throat/top of chest like difficulty breating, itchy nose, congestion, eyesight not clear, dizziness, few hives on face, pain at site of injection and down arm and into hand, hand was pulsing as if it had been hurt, pain at base of skull on left side of head, accelerated heart beat, followed by headache.  Very frightening feeling.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Heart rate increased, Injection site pain, Nervousness, Pain in extremity, Pruritus
Clinical narrative: Weak, shaky, feeling at base of throat/top of chest like difficulty breating, itchy nose, congestion, eyesight not clear, dizziness, few hives on face, pain at site of injection and down arm and into hand, hand was pulsing as if it had been hurt, pain at base of skull on left side of head, accelerated heart beat, followed by headache.  Very frightening feeling.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Respiratory tract congestion, Throat irritation, Urticaria, Vision blurred
Clinical narrative: Weak, shaky, feeling at base of throat/top of chest like difficulty breating, itchy nose, congestion, eyesight not clear, dizziness, few hives on face, pain at site of injection and down arm and into hand, hand was pulsing as if it had been hurt, pain at base of skull on left side of head, accelerated heart beat, followed by headache.  Very frightening feeling.
Age: 15.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Asthma, Cough, Dizziness, Dyspnoea, Headache
Clinical narrative: 9/12/12 started coughing; 9/13/12 runny nose and sore throat; 9/14/12 chills, no fever; 9/16/12 @ 5PM difficulty breathing, dizzy, headache; 9/17/12 seen by MD, put on prednisone, nebulizer, ventalin inhaler-MD diagnosed asthma; 9/18/12 taken to ED, given nebulizer treatments and prednisone injection; 9/20/12 brought to ED- given penicillin and cough medication.
Age: 15.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Oropharyngeal pain, Rhinorrhoea
Clinical narrative: 9/12/12 started coughing; 9/13/12 runny nose and sore throat; 9/14/12 chills, no fever; 9/16/12 @ 5PM difficulty breathing, dizzy, headache; 9/17/12 seen by MD, put on prednisone, nebulizer, ventalin inhaler-MD diagnosed asthma; 9/18/12 taken to ED, given nebulizer treatments and prednisone injection; 9/20/12 brought to ED- given penicillin and cough medication.
Age: 14.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Balance disorder, Dizziness, Fall, Head injury, Headache
Clinical narrative: She reported to the school nurse having a headache and dizziness after administration of the vaccine which is persisting today. The school nurse reports that she became so dizzy she lost balance and fell in the parking lot hitting her head. When discussing the previous 2 HPV vaccines she received with her she notes that she did feel on the verge of passing out for the remainder of the day with each.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood test normal, Immediate post-injection reaction, Pain, Tendon disorder
Clinical narrative: Flu vaccine administered very high on left shoulder. Immediate pain radiating from shoulder to elbow.  Painful to use left arm for simple tasks and loss of strength.  Diagnosed by rheumatologist as "shoulder tendinopathy".  Currently undergoing physical therapy.  As of the date of this post, pain has not subsided at all.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: Flu vaccine administered very high on left shoulder. Immediate pain radiating from shoulder to elbow.  Painful to use left arm for simple tasks and loss of strength.  Diagnosed by rheumatologist as "shoulder tendinopathy".  Currently undergoing physical therapy.  As of the date of this post, pain has not subsided at all.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient was given Fluzone, flu shot. He is just shy of 2 months old. Patient was not supposed to receive shot until 6 months of age.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Dizziness, Hot flush, Hyperhidrosis, Injection site pain
Clinical narrative: Generalized sweating, "hot flashes", anxiety.  Slight dizziness.  No respiratory distress, no wheezing, no labial swelling, no hives.  No hypotension. BP 150/80, then 130/80, pulse 80-90. Temp 98.0F. Slight flushing noted on anterior chest. Sxs lasted for 3 hours after receiving shot.  Pt took Diphenhydramine 50mg at 4pm and by 6pm reports feeling better, but drowsy.  By 10pm, sxs resolved.  By next morning, pt denies any sxs, no remaining sweating, dizziness or flushing.  Only complaint is tenderness at injection site.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Somnolence
Clinical narrative: Generalized sweating, "hot flashes", anxiety.  Slight dizziness.  No respiratory distress, no wheezing, no labial swelling, no hives.  No hypotension. BP 150/80, then 130/80, pulse 80-90. Temp 98.0F. Slight flushing noted on anterior chest. Sxs lasted for 3 hours after receiving shot.  Pt took Diphenhydramine 50mg at 4pm and by 6pm reports feeling better, but drowsy.  By 10pm, sxs resolved.  By next morning, pt denies any sxs, no remaining sweating, dizziness or flushing.  Only complaint is tenderness at injection site.
Age: 1.73
Sex: F
Vaccine: FLU3, HEPA, PNC13
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Dizziness, Insomnia, Nasal congestion
Clinical narrative: 11/16/12 - 2:35 p.m. - Lightheadedness. 11/17/12 - 10:30 p.m. - Joint pain [600 mg Ibuprofen effectively reduced symptoms], sleeplessness. 11/18/12 - 7:00 p.m. - 2:00 a.m. - Nasal congestion, body aches, drowsiness. 11/19/12 - 9:20 a.m. - midnight - Nasal congestion, body aches. 11/20/12 - 4:30 a.m. - nausea, abdominal pain, nasal congestion, body aches.  9:15 a.m. - nasal congestion, body aches, joint pain, chills.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: 11/16/12 - 2:35 p.m. - Lightheadedness. 11/17/12 - 10:30 p.m. - Joint pain [600 mg Ibuprofen effectively reduced symptoms], sleeplessness. 11/18/12 - 7:00 p.m. - 2:00 a.m. - Nasal congestion, body aches, drowsiness. 11/19/12 - 9:20 a.m. - midnight - Nasal congestion, body aches. 11/20/12 - 4:30 a.m. - nausea, abdominal pain, nasal congestion, body aches.  9:15 a.m. - nasal congestion, body aches, joint pain, chills.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Rash erythematous
Clinical narrative: Red spots on back and chest, showed 10 days after vaccination. Patient went to Medical Center on 17 Nov 12 and states was prescribed Benadryl. Patient had follow up visit with Dr on 20 Nov 12 and was exempted from future Smallpox vaccine.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Musculoskeletal stiffness, Unresponsive to stimuli
Clinical narrative: Alert and oriented prior to injection. Almost immediately after injection of Hep B client stated she felt faint. She was unresponsive to voice for approximately five seconds and her legs stiffened. Client was responsive to voice again and stated she wanted to lay down. Kept client in clinic for 30 minutes after event for monitoring. Her HR immediately after injection was 60, prior to leaving clinic it was 70 and she was ambulating with a steady gait.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye disorder, VIIth nerve paralysis
Clinical narrative: Changes in eyes and one side of face.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Lymphadenopathy, Oedema peripheral
Clinical narrative: Arm was swollen and red, lymph area underarm swollen as well.  Per pt, dr is treating as cellulitis?
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Computerised tomogram abnormal, Computerised tomogram head, Congenital central nervous system anomaly, Eye movement disorder, Gaze palsy
Clinical narrative: 45 sec. episode of rolling of eyeballs. Taken to hospital. Flickering movements of both eyes lasting approx. 15 min. Discharged home on Phenobarbital.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Thrombophlebitis superficial
Clinical narrative: This initial information was received from a nurse concerning an approximately 34 years old female patient with diabetes, simvastatin (manufacturer unknown) allergy (CASE #1211USA007941), LIPITOR allergy, VYTORIN allergy (Case#1211USA008157) and latex allergy who on 01-NOV-2012, the patient was vaccinated intramuscularly in the right arm with a dose of 0.5 ml PNEUMOVAX23 lot # (H012650), exp date 27-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. It was reported that on 01-NOV-2012 the patient developed redness and swelling at the injection site of the right arm 5 hours after administration of PNEUMOVAX23. The patient was evaluated at the emergency room on the same date and was treated with vancomycin IV and LOVENOX injection. On 02-NOV-2012, the patient was evaluated in the emergency room again and was diagnosed with a superficial thrombosis of the right cephalic vein. On the same date, the patient was admitted to the hospital and on 04-NOV-2012, the patient was discharged from the hospital. Details of hospitalization were not known at the time of report. The nurse stated that the thrombosis was attributed to a reaction to the IV administration of vancomycin. On an unspecified date, the patient recovered from the events. It was reported that the patient sought medical attention by going to hospital. This is one of several reports from the same source. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Breast mass, Breast tenderness, Central venous catheterisation, Chills, Mastitis
Clinical narrative: This retrospective pregnancy case was reported by a healthcare professional and described the occurrence of fever in a 33-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline) after pregnancy. Concurrent medical conditions included penicillin allergy. Pregnant and delivered baby 05 October 2012. On 25 October 2012 the subject received unspecified dose of FLULAVAL (unknown, left arm). The subject had delivered a baby on 05 October 2012 and she was breast feeding; details regarding the pregnancy and birth were not provided. On 26 October 2012, one day after vaccination with FLULAVAL, the subject experienced fever, chills, mastitis-r breast, and breast lump. The subject was treated with cephalexin. On or about 27 or 28 October 2012, 2 days after vaccination with FLULAVAL, the subject experienced 1 breast tenderness and arm weakness. On 31 October 2012, 6 days after vaccination with FLULAVAL, the subject experienced high fever of 102.3 degrees Fahrenheit. The subject was hospitalized on an unspecified date and discharged on 02 November 2012. The subject was treated with vancomycin. The subject was hospitalized and the healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the fever, chills, r breast mastitis and breast lump were improved; the high fever resolved on 02 November 2012 and left breast tenderness and left arm weakness resolved on 05 November 2012. The subject had been pregnant and delivered on 05 October 2012 and is breast feeding. She received FLULAVAL and developed a fever, chills, right side mastitis, lump was treated for a couple of days with outpatient oral cephalexin. Then she developed a high fever of 102.3 degrees Fahrenheit, breast tenderness on left side (side of arm with injection) with left arm weakness. She was hospitalized and started on a pic-line and discharged home receiving home intravenous therapy with vancomycin, weakness and left sided problems resolved as of 05 November 2012. No cultures no abscess seen on ultrasound. Please see case A10001266B regarding the baby and vaccine exposure via breast milk.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Pyrexia, Ultrasound scan normal
Clinical narrative: This retrospective pregnancy case was reported by a healthcare professional and described the occurrence of fever in a 33-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline) after pregnancy. Concurrent medical conditions included penicillin allergy. Pregnant and delivered baby 05 October 2012. On 25 October 2012 the subject received unspecified dose of FLULAVAL (unknown, left arm). The subject had delivered a baby on 05 October 2012 and she was breast feeding; details regarding the pregnancy and birth were not provided. On 26 October 2012, one day after vaccination with FLULAVAL, the subject experienced fever, chills, mastitis-r breast, and breast lump. The subject was treated with cephalexin. On or about 27 or 28 October 2012, 2 days after vaccination with FLULAVAL, the subject experienced 1 breast tenderness and arm weakness. On 31 October 2012, 6 days after vaccination with FLULAVAL, the subject experienced high fever of 102.3 degrees Fahrenheit. The subject was hospitalized on an unspecified date and discharged on 02 November 2012. The subject was treated with vancomycin. The subject was hospitalized and the healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the fever, chills, r breast mastitis and breast lump were improved; the high fever resolved on 02 November 2012 and left breast tenderness and left arm weakness resolved on 05 November 2012. The subject had been pregnant and delivered on 05 October 2012 and is breast feeding. She received FLULAVAL and developed a fever, chills, right side mastitis, lump was treated for a couple of days with outpatient oral cephalexin. Then she developed a high fever of 102.3 degrees Fahrenheit, breast tenderness on left side (side of arm with injection) with left arm weakness. She was hospitalized and started on a pic-line and discharged home receiving home intravenous therapy with vancomycin, weakness and left sided problems resolved as of 05 November 2012. No cultures no abscess seen on ultrasound. Please see case A10001266B regarding the baby and vaccine exposure via breast milk.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Erythema, Pruritus, Rash, Swelling
Clinical narrative: Redness/swelling, blisters, rash & itching started occurring day after vaccine adm. and progressed. 11/18/12 Pt told to take BENADRYL and to see MD if symptoms did not resolve. No resolution pt going to MD 11/20/12.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Extreme pain in (R) arm, fever at 101.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Formication, Insomnia, Pain, Paraesthesia
Clinical narrative: Itching at body, intensified throughout day & into evening after receiving vaccine. Feeling of crawlies/tingling all over. Rash all over body. Pt felt tired-exhausted. Woke up in AM, rash decreased, itching decreased, however, achy. Patient called in at 7:30pm on 11/19/2012, concerned that she might have had a reaction to the flu shot she received at 1 pm, on 11/18/2012. She said she experienced itchiness that started after she received the shot and intensified during the course of the day and into the evening. She took 2 BENADRYL tabs (1 at 11:30pm, and 1 at 230am) hoping to help with the itching. She also mentioned that she felt "tingling/crawlies" all over her body with the itching that she experienced. No fever. She noticed that she developed that rash all over her body (which appeared BEFORE she scratched her itchy skin). In the evening, she felt exhausted but she couldn't sleep. She fell asleep at around 230 am (which could be a result of the BENADRYL). When she woke up at 630am, she was still itchy, but it's not as intense and the rash has decreased. She felt achy though. Pt currently has fibromyalgia, endometriosis and allergies which she gets shots for (her last appointment was 2 weeks ago). She has not started any new medications lately. I checked the monograph and I didn't find the side effects specifically addressing the "crawlies" that she experienced. I told her that the most common SE is the localized rash and the "achiness" she felt in the morning is also common. Pt mentioned that there is a possibility that it could be her fibromyalgia. I told her that we will call the MFR to verify any post marketing data about the "crawlies (the monograph mentioned "paresthesia" as a SE but I didn't know if the "crawlies" would fall under this guideline). I also called and left message for employee to call back about it tomorrow. Talk to her first before calling MFR. Pt has had shots of FLUVIRIN for 2010-11 and 2009-10 seasons at our pharmacy. Please call pt with any info. We might want to let her MD know about reaction to vaccine. If this seems like an "allergic" reaction (which it doesn't seem like it is), pls call Dr who is her allergist. 847pm per staff possibly urticaria syndrome. 849pm called pt & explained urticaria possibility with pt resolved. Call 911 if recurs, call MD 1st thing in am for follow-up.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Rash generalised, Vaccination complication
Clinical narrative: Itching at body, intensified throughout day & into evening after receiving vaccine. Feeling of crawlies/tingling all over. Rash all over body. Pt felt tired-exhausted. Woke up in AM, rash decreased, itching decreased, however, achy. Patient called in at 7:30pm on 11/19/2012, concerned that she might have had a reaction to the flu shot she received at 1 pm, on 11/18/2012. She said she experienced itchiness that started after she received the shot and intensified during the course of the day and into the evening. She took 2 BENADRYL tabs (1 at 11:30pm, and 1 at 230am) hoping to help with the itching. She also mentioned that she felt "tingling/crawlies" all over her body with the itching that she experienced. No fever. She noticed that she developed that rash all over her body (which appeared BEFORE she scratched her itchy skin). In the evening, she felt exhausted but she couldn't sleep. She fell asleep at around 230 am (which could be a result of the BENADRYL). When she woke up at 630am, she was still itchy, but it's not as intense and the rash has decreased. She felt achy though. Pt currently has fibromyalgia, endometriosis and allergies which she gets shots for (her last appointment was 2 weeks ago). She has not started any new medications lately. I checked the monograph and I didn't find the side effects specifically addressing the "crawlies" that she experienced. I told her that the most common SE is the localized rash and the "achiness" she felt in the morning is also common. Pt mentioned that there is a possibility that it could be her fibromyalgia. I told her that we will call the MFR to verify any post marketing data about the "crawlies (the monograph mentioned "paresthesia" as a SE but I didn't know if the "crawlies" would fall under this guideline). I also called and left message for employee to call back about it tomorrow. Talk to her first before calling MFR. Pt has had shots of FLUVIRIN for 2010-11 and 2009-10 seasons at our pharmacy. Please call pt with any info. We might want to let her MD know about reaction to vaccine. If this seems like an "allergic" reaction (which it doesn't seem like it is), pls call Dr who is her allergist. 847pm per staff possibly urticaria syndrome. 849pm called pt & explained urticaria possibility with pt resolved. Call 911 if recurs, call MD 1st thing in am for follow-up.
Age: 18.0
Sex: M
Vaccine: FLUX
Symptoms: Back pain, Chills, Gait disturbance, Headache, Urticaria
Clinical narrative: Immunization (Influenza) at 3 pm. 9:30 pm - headache, chills, blurry vision, unsteady gait, back "soreness" symptoms continue today 11/14/12 with hives on inner thighs & side of knees.