chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: YF
Symptoms: Chest discomfort, Nasal congestion, Ocular hyperaemia, Pruritus, Pyrexia
Clinical narrative: Throat closing, chest tight, wheezing, bloodshot eyes, ears itching, nose dripping, congested nose, slight fever.
Age: 20.0
Sex: F
Vaccine: YF
Symptoms: Rhinorrhoea, Throat tightness, Wheezing
Clinical narrative: Throat closing, chest tight, wheezing, bloodshot eyes, ears itching, nose dripping, congested nose, slight fever.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal operation, Enema administration, Haematochezia
Clinical narrative: Pt traveled out of the country. Per mom, had bloody stool on 4/19/16. Contrast enema out of the country was unsuccessful, underweight abdominal surgery. Surgery successful.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Muscle disorder, Muscle rupture
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a 71 year old male patient. Information regarding his pertinent medical history, drug reactions/ allergies and concurrent conditions were not reported. On 20-MAY-2016, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX, subcutaneously (dosage number, anatomical location, lot # and expiration date were not reported). No concomitant medications were reported. On 23-MAY-2016, exactly three days after the vaccination, an unspecified pectoral muscle of the patient became "detached". Subsequently, on an unspecified date in May 2016, he was reported to have struggled in an unspecified way while walking his dog, dog to the muscle issue. The details regarding whether the patient sought medical attention or received treatment for the adverse event were not reported. No product quality complaint was involved. At the time of reporting, the outcome of the muscle rupture and muscle disorder were unknown. The reporter also failed to provide a causal relationship between the events and the vaccination with ZOSTAVAX. Additional information has been requested.
Age: 0.89
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Computerised tomogram head, Electrocardiogram, Electroencephalogram, Full blood count, Metabolic function test
Clinical narrative: Pt developed new onset seizure 5 days after the vaccine given. Pt was admitted through ER (via ambulance) and following tests were ordered. Pt started on DILANTIN, lorazepam and discharged on DILANTIN.
Age: 0.89
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Nuclear magnetic resonance imaging brain, Seizure, Urine analysis
Clinical narrative: Pt developed new onset seizure 5 days after the vaccine given. Pt was admitted through ER (via ambulance) and following tests were ordered. Pt started on DILANTIN, lorazepam and discharged on DILANTIN.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pallor, Seizure
Clinical narrative: This is a spontaneous report from a contactable nurse received via a sales representative. A 16-year-old female patient received TRUMENBA in left arm, at single dose and MENACTRA in right arm, both via an unspecified route of administration, on an unspecified date. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced seizure and loss of color, both on an unspecified date, with unknown outcome.
Age: 58.0
Sex: M
Vaccine: PNC13, TTOX, UNK, HEP, HEPA, PNC13, TTOX, HEP, PNC13, TDAP
Symptoms: Blood test normal, Chest X-ray normal, Chest discomfort, Chest pain, Pain
Clinical narrative: This is a spontaneous report obtained from a contactable consumer who reported for her husband. A 58-year-old male patient received, on 19May2016, in the afternoon, the second dose of PREVNAR 13 0.5 ml, single dose, tetanus vaccine and hepatitis series vaccines. Relevant medical history included renal failure (the patient was in the last stages of renal failure and he was going to get a kidney transplant. The preliminary requirement to get a kidney transplant was to have hepatitis series, the tetanus and pneumococcal 13-val con vac). He did not have other issues. The patient received an unspecified concomitant medications. The patient received the first shot of PREVNAR 13 on 14Apr2016, at 0.5 ml, single dose. On 20May2016, at 04:30, in the morning, the patient experienced heaviness on his chest. The patient described it as "a stabbing pain" and it lasted for 5 minutes. Hospitalization was required. The patient was put on heart monitor and a whole series of blood work were performed. Chest x-ray with the isotopes ruled out any kind of blood "clots" in the lungs and they also ruled out a heart attack. The patient recovered from the events, on 20May2016.
Age: 58.0
Sex: M
Vaccine: PNC13, TTOX, UNK, HEP, HEPA, PNC13, TTOX, HEP, PNC13, TDAP
Symptoms: Blood test, Cardiac monitoring, Chest X-ray normal, Chest discomfort, Chest pain
Clinical narrative: This is a spontaneous report obtained from a contactable consumer who reported for her husband. A 58-year-old male patient received, on 19May2016, in the afternoon, the second dose of PREVNAR 13 0.5 ml, single dose, tetanus vaccine and hepatitis series vaccines. Relevant medical history included renal failure (the patient was in the last stages of renal failure and he was going to get a kidney transplant. The preliminary requirement to get a kidney transplant was to have hepatitis series, the tetanus and pneumococcal 13-val con vac). He did not have other issues. The patient received an unspecified concomitant medications. The patient received the first shot of PREVNAR 13 on 14Apr2016, at 0.5 ml, single dose. On 20May2016, at 04:30, in the morning, the patient experienced heaviness on his chest. The patient described it as "a stabbing pain" and it lasted for 5 minutes. Hospitalization was required. The patient was put on heart monitor and a whole series of blood work were performed. Chest x-ray with the isotopes ruled out any kind of blood "clots" in the lungs and they also ruled out a heart attack. The patient recovered from the events, on 20May2016.
Age: 58.0
Sex: M
Vaccine: PNC13, TTOX, UNK, HEP, HEPA, PNC13, TTOX, HEP, PNC13, TDAP
Symptoms: Blood test normal, Chest X-ray normal, Chest discomfort, Extra dose administered, Pain
Clinical narrative: This is a spontaneous report obtained from a contactable consumer who reported for her husband. A 58-year-old male patient received, on 19May2016, in the afternoon, the second dose of PREVNAR 13 0.5 ml, single dose, tetanus vaccine and hepatitis series vaccines. Relevant medical history included renal failure (the patient was in the last stages of renal failure and he was going to get a kidney transplant. The preliminary requirement to get a kidney transplant was to have hepatitis series, the tetanus and pneumococcal 13-val con vac). He did not have other issues. The patient received an unspecified concomitant medications. The patient received the first shot of PREVNAR 13 on 14Apr2016, at 0.5 ml, single dose. On 20May2016, at 04:30, in the morning, the patient experienced heaviness on his chest. The patient described it as "a stabbing pain" and it lasted for 5 minutes. Hospitalization was required. The patient was put on heart monitor and a whole series of blood work were performed. Chest x-ray with the isotopes ruled out any kind of blood "clots" in the lungs and they also ruled out a heart attack. The patient recovered from the events, on 20May2016.
Age: 58.0
Sex: M
Vaccine: PNC13, TTOX, UNK, HEP, HEPA, PNC13, TTOX, HEP, PNC13, TDAP
Symptoms: Radioisotope scan normal, Wrong drug administered
Clinical narrative: This is a spontaneous report obtained from a contactable consumer who reported for her husband. A 58-year-old male patient received, on 19May2016, in the afternoon, the second dose of PREVNAR 13 0.5 ml, single dose, tetanus vaccine and hepatitis series vaccines. Relevant medical history included renal failure (the patient was in the last stages of renal failure and he was going to get a kidney transplant. The preliminary requirement to get a kidney transplant was to have hepatitis series, the tetanus and pneumococcal 13-val con vac). He did not have other issues. The patient received an unspecified concomitant medications. The patient received the first shot of PREVNAR 13 on 14Apr2016, at 0.5 ml, single dose. On 20May2016, at 04:30, in the morning, the patient experienced heaviness on his chest. The patient described it as "a stabbing pain" and it lasted for 5 minutes. Hospitalization was required. The patient was put on heart monitor and a whole series of blood work were performed. Chest x-ray with the isotopes ruled out any kind of blood "clots" in the lungs and they also ruled out a heart attack. The patient recovered from the events, on 20May2016.
Age: 61.0
Sex: F
Vaccine: FLU3, HEPA, YF, FLU3, HEPA, YF
Symptoms: Computerised tomogram, Hypoaesthesia, Immediate post-injection reaction, Laboratory test, Leg amputation
Clinical narrative: Immediate pain in right calf, proceeding to numbness, coldness, and pain in right foot. Blood clot (no vascular disease) discovered, subsequent amputation below the knee.
Age: 61.0
Sex: F
Vaccine: FLU3, HEPA, YF, FLU3, HEPA, YF
Symptoms: Pain in extremity, Peripheral coldness, Thrombosis
Clinical narrative: Immediate pain in right calf, proceeding to numbness, coldness, and pain in right foot. Blood clot (no vascular disease) discovered, subsequent amputation below the knee.
Age: 61.0
Sex: F
Vaccine: FLU3, HEPA, YF, FLU3, HEPA, YF
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Leg amputation, Pain in extremity, Peripheral coldness
Clinical narrative: Immediate pain in right calf, proceeding to numbness, coldness, and pain in right foot. Blood clot (no vascular disease) discovered, subsequent amputation below the knee.
Age: 61.0
Sex: F
Vaccine: FLU3, HEPA, YF, FLU3, HEPA, YF
Symptoms: Thrombosis
Clinical narrative: Immediate pain in right calf, proceeding to numbness, coldness, and pain in right foot. Blood clot (no vascular disease) discovered, subsequent amputation below the knee.
Age: 12.0
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Heart rate increased, Pruritus, Radioallergosorbent test negative, Rash
Clinical narrative: This medically confirmed literature case (initial receipt 16-Dec-2015) concerns a 12 year old female patient. The author identified confirmed cases of anaphylaxis from the Vaccine Safety Datalink from vaccination records from January 2009 through December 2011. The patient had a history of atopy: allergy to penicillin. On an unspecified date between 01-Jan-2009 through 31-Dec-2011, the patient received influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, 1 day after vaccination, the patient experienced anaphylaxis. Her symptoms included generalised urticaria, pruritus, rash, increased heart rate, syncope, blood pressure at 117/72 mmHg and lump in throat. The case met Brighton Collaboration case definition of anaphylaxis criteria level 2. The patient was kept as an inpatient overnight. She received treatment with epinephrine, parenteral antihistamine, parenteral H2-blocker, oral steroid, oxygen, antiemetic and lidocaine cream. The patient was referred to allergist. Her skin test and RAST (radioallergosorbent test) results were both negative for latex The patient was prescribed epinephrine autoinjector. The outcome was recovered. Reporter's comments: The attributed trigger was vaccine.
Age: 12.0
Sex: F
Vaccine: FLUX
Symptoms: Sensation of foreign body, Skin test negative, Syncope, Urticaria
Clinical narrative: This medically confirmed literature case (initial receipt 16-Dec-2015) concerns a 12 year old female patient. The author identified confirmed cases of anaphylaxis from the Vaccine Safety Datalink from vaccination records from January 2009 through December 2011. The patient had a history of atopy: allergy to penicillin. On an unspecified date between 01-Jan-2009 through 31-Dec-2011, the patient received influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, 1 day after vaccination, the patient experienced anaphylaxis. Her symptoms included generalised urticaria, pruritus, rash, increased heart rate, syncope, blood pressure at 117/72 mmHg and lump in throat. The case met Brighton Collaboration case definition of anaphylaxis criteria level 2. The patient was kept as an inpatient overnight. She received treatment with epinephrine, parenteral antihistamine, parenteral H2-blocker, oral steroid, oxygen, antiemetic and lidocaine cream. The patient was referred to allergist. Her skin test and RAST (radioallergosorbent test) results were both negative for latex The patient was prescribed epinephrine autoinjector. The outcome was recovered. Reporter's comments: The attributed trigger was vaccine.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Abnormal behaviour, Asthenia, Depression, Eating disorder, Feeling abnormal
Clinical narrative: This spontaneous report as received from a healthcare professional refers to her daughter of unknown age. The patient's pertinent medical history and drug reactions or allergies were not reported. On 02-JAN-2015 the patient was vaccinated with hepatitis B vaccine (recombinant) (manufacturer unknown) (dose 1, therapy route intramuscular and lot number was not reported). Concomitant medications were not reported. Approximately in February 2015, one month after receiving the hepatitis B vaccine (recombinant) (manufacturer unknown), the patient experienced problems at school event, behavioral changes, felt very weak, did not eat or sleep well, very depressed and having suicidal thoughts. The patient was hospitalized for 20 days from 04-FEB-2015 till 23-FEB-2015. Healthcare worker reported patient was doing better after release from hospital. On 05-FEB-2016 the patient received second dose of hepatitis B vaccine (recombinant) (manufacturer unknown) (inappropriate schedule of vaccine administration) and other suspect therapy M-M-R II (dosage information and lot number was not reported). It was reported that, in middle of MARCH 2016, the patient fell apart, patient's personality and behavior seemed different, more talkative, seemed less like herself, faster than usual. It was also reported that patient experienced "talking not making sense" and patient was not presenting "a typical manner". On 28-APR-2016, the patient was hospitalized. At the time of reporting the patient was still remained admitted into hospital. The healthcare worker would be meeting with unspecified physicians, on 27-MAY-2016. The outcome of feeling abnormal, general physical condition abnormal, babbling, personality disorder and logorrhea was unknown. Causality assessment was not provided. No product complaint was reported. Upon internal review "suicidal thoughts" was determined to be medically significant. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: General physical condition abnormal, Inappropriate schedule of drug administration, Logorrhoea, Personality change, Poor quality sleep
Clinical narrative: This spontaneous report as received from a healthcare professional refers to her daughter of unknown age. The patient's pertinent medical history and drug reactions or allergies were not reported. On 02-JAN-2015 the patient was vaccinated with hepatitis B vaccine (recombinant) (manufacturer unknown) (dose 1, therapy route intramuscular and lot number was not reported). Concomitant medications were not reported. Approximately in February 2015, one month after receiving the hepatitis B vaccine (recombinant) (manufacturer unknown), the patient experienced problems at school event, behavioral changes, felt very weak, did not eat or sleep well, very depressed and having suicidal thoughts. The patient was hospitalized for 20 days from 04-FEB-2015 till 23-FEB-2015. Healthcare worker reported patient was doing better after release from hospital. On 05-FEB-2016 the patient received second dose of hepatitis B vaccine (recombinant) (manufacturer unknown) (inappropriate schedule of vaccine administration) and other suspect therapy M-M-R II (dosage information and lot number was not reported). It was reported that, in middle of MARCH 2016, the patient fell apart, patient's personality and behavior seemed different, more talkative, seemed less like herself, faster than usual. It was also reported that patient experienced "talking not making sense" and patient was not presenting "a typical manner". On 28-APR-2016, the patient was hospitalized. At the time of reporting the patient was still remained admitted into hospital. The healthcare worker would be meeting with unspecified physicians, on 27-MAY-2016. The outcome of feeling abnormal, general physical condition abnormal, babbling, personality disorder and logorrhea was unknown. Causality assessment was not provided. No product complaint was reported. Upon internal review "suicidal thoughts" was determined to be medically significant. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Speech disorder, Suicidal ideation
Clinical narrative: This spontaneous report as received from a healthcare professional refers to her daughter of unknown age. The patient's pertinent medical history and drug reactions or allergies were not reported. On 02-JAN-2015 the patient was vaccinated with hepatitis B vaccine (recombinant) (manufacturer unknown) (dose 1, therapy route intramuscular and lot number was not reported). Concomitant medications were not reported. Approximately in February 2015, one month after receiving the hepatitis B vaccine (recombinant) (manufacturer unknown), the patient experienced problems at school event, behavioral changes, felt very weak, did not eat or sleep well, very depressed and having suicidal thoughts. The patient was hospitalized for 20 days from 04-FEB-2015 till 23-FEB-2015. Healthcare worker reported patient was doing better after release from hospital. On 05-FEB-2016 the patient received second dose of hepatitis B vaccine (recombinant) (manufacturer unknown) (inappropriate schedule of vaccine administration) and other suspect therapy M-M-R II (dosage information and lot number was not reported). It was reported that, in middle of MARCH 2016, the patient fell apart, patient's personality and behavior seemed different, more talkative, seemed less like herself, faster than usual. It was also reported that patient experienced "talking not making sense" and patient was not presenting "a typical manner". On 28-APR-2016, the patient was hospitalized. At the time of reporting the patient was still remained admitted into hospital. The healthcare worker would be meeting with unspecified physicians, on 27-MAY-2016. The outcome of feeling abnormal, general physical condition abnormal, babbling, personality disorder and logorrhea was unknown. Causality assessment was not provided. No product complaint was reported. Upon internal review "suicidal thoughts" was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: FLUX, FLUX
Symptoms: Condition aggravated, Guillain-Barre syndrome
Clinical narrative: This medically confirmed spontaneous report (initial receipt 02-Nov-2015) concerns a patient (unknown demographics). On an unspecified date, the patient received a dose of an unspecified influenza vaccine (Influenza virus vaccine, manufacture and batch number not provided). On an unspecified date following the influenza vaccine administration, the patient developed Guillain Barre Syndrome. No further information provided. The outcome was not provided. Follow-up information received on 13-Nov-2015 from the pharmacist: The cause of the GBS was not known by the reporter.
Age: 5.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Anaphylactic reaction, Dyspnoea, Pruritus, Rash, Urticaria
Clinical narrative: This medically confirmed literature case (initial receipt 16-Dec-2015) concerns a 5 year old male patient. The author identified confirmed cases of anaphylaxis from the Vaccine Safety Datalink from vaccination records from January 2009 through December 2011. The patient had a medical history of atopy: asthma and 'other (cashew and pistachio nuts)'. On an unspecified date between 01-Jan-2009 through 31-Dec-2011, the patient received trivalent influenza vaccine (manufacturer and batch number not reported). On an unspecified date, 3 hours after vaccination, the patient experienced anaphylaxis. The symptoms included generalized urticarial, pruritus, rash and shortness of breath. The case met Brighton Collaboration case definition of anaphylaxis criteria level 2. He received treatment with oral antihistamines and oral steroids. The outcome was recovered. Reporter's comments: The attributed trigger was vaccine.
Age: 36.0
Sex: F
Vaccine: FLUX, TDAP, FLUX, TDAP
Symptoms: Anaphylactic reaction, Angioedema, Choking, Cough, Heart rate increased
Clinical narrative: This medically confirmed literature case (initial receipt 16-Dec-2015) concerns a 36 year old female patient. The author identified confirmed cases of anaphylaxis from the Vaccine Safety Datalink from vaccination records from January 2009 through December 2011. The patient had a history atopy: contact dermatitis and allergic rhinitis. On an unspecified date between 01-Jan-2009 through 31-Dec-2011, the patient received influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, 3 hours after vaccination, the patient experienced anaphylaxis. The symptoms included angioedema, 'choking' cough, increased heart rate and nausea. The case met Brighton Collaboration case definition of anaphylaxis criteria level 2. She received treatment with oral antihistamine, oral steroid and cool compress. The outcome was recovered. Reporter's comments: The attributed trigger was vaccine.
Age: 36.0
Sex: F
Vaccine: FLUX, TDAP, FLUX, TDAP
Symptoms: Nausea
Clinical narrative: This medically confirmed literature case (initial receipt 16-Dec-2015) concerns a 36 year old female patient. The author identified confirmed cases of anaphylaxis from the Vaccine Safety Datalink from vaccination records from January 2009 through December 2011. The patient had a history atopy: contact dermatitis and allergic rhinitis. On an unspecified date between 01-Jan-2009 through 31-Dec-2011, the patient received influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, 3 hours after vaccination, the patient experienced anaphylaxis. The symptoms included angioedema, 'choking' cough, increased heart rate and nausea. The case met Brighton Collaboration case definition of anaphylaxis criteria level 2. She received treatment with oral antihistamine, oral steroid and cool compress. The outcome was recovered. Reporter's comments: The attributed trigger was vaccine.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Dyspnoea, Heart rate increased, Nasal congestion, Nausea
Clinical narrative: This medically confirmed literature case (initial receipt 16-Dec-2015) concerns a 26-year-old female patient. The author identified confirmed cases of anaphylaxis from the Vaccine Safety Datalink from vaccination records from January 2009 through December 2011. The patient had a history atopy: asthma. On an unspecified date between 01-Jan-2009 through 31-Dec-2011, the patient received influenza virus vaccine (manufacturer and batch number not reported) and PPV 223 (batch number not reported). On an unspecified date, (onset after vaccination not documented), the patient experienced anaphylaxis. The symptoms included wheeze (bilateral), shortness of breath, increased heart rate, nasal congestion and nausea. The case met Brighton Collaboration case definition of anaphylaxis criteria level 2. She received treatment with nebulizer. The outcome was recovered. Reporter's comments: The attributed trigger was vaccine.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Wheezing
Clinical narrative: This medically confirmed literature case (initial receipt 16-Dec-2015) concerns a 26-year-old female patient. The author identified confirmed cases of anaphylaxis from the Vaccine Safety Datalink from vaccination records from January 2009 through December 2011. The patient had a history atopy: asthma. On an unspecified date between 01-Jan-2009 through 31-Dec-2011, the patient received influenza virus vaccine (manufacturer and batch number not reported) and PPV 223 (batch number not reported). On an unspecified date, (onset after vaccination not documented), the patient experienced anaphylaxis. The symptoms included wheeze (bilateral), shortness of breath, increased heart rate, nasal congestion and nausea. The case met Brighton Collaboration case definition of anaphylaxis criteria level 2. She received treatment with nebulizer. The outcome was recovered. Reporter's comments: The attributed trigger was vaccine.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 27 year-old male patient. On 08-Oct-2016, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5 mL. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 45 year-old female patient. On 08-Oct-2015, the patient received AFLURIA (batch number: U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5 mL. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for not more than 23 hours. The outcome was not reported.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria, Pain
Clinical narrative: Described arms as feeling tingly, like icy hot was applies to both upper arms, woke up on Tues am with itching around the site of injections (both arms) hives with redness and swelling around injection site. Painful to move both UE.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Paraesthesia
Clinical narrative: Described arms as feeling tingly, like icy hot was applies to both upper arms, woke up on Tues am with itching around the site of injections (both arms) hives with redness and swelling around injection site. Painful to move both UE.
Age: 42.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, X-ray
Clinical narrative: Injection site reaction. swelling, warm to touch and red.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Asthenia, Hyporesponsive to stimuli, Lethargy, Pallor, Vomiting
Clinical narrative: She woke up extremely lethargic and weak, almost unresponsive.  Was extremely pale, almost gray. Finally got up out of bed, and vomited in the hallway.
Age: 94.0
Sex: F
Vaccine: PNC, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Redness, Warmth and itchiness present at injection site.
Age: 50.0
Sex: F
Vaccine: HEPAB
Symptoms: Biopsy skin abnormal, Pruritus, Rash erythematous, Rash pruritic, Skin lesion
Clinical narrative: Red spots began to appear on legs, in time spread to 90% of my body, red, rash, itchy legions/spots.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: Vomited several times.
Age: 16.0
Sex: F
Vaccine: HPV9, MMR, VARCEL
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient began to feel faint and passed out.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Asthenia, Dizziness, Hypotension, Nausea, Vertigo
Clinical narrative: Employee states that within 15-20 minutes after receiving the vaccine, she began experiencing dizziness. The next day she experienced nausea, vomiting, vertigo and weakness and low blood pressure. These symptoms continued for approx. 3 days.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: Employee states that within 15-20 minutes after receiving the vaccine, she began experiencing dizziness. The next day she experienced nausea, vomiting, vertigo and weakness and low blood pressure. These symptoms continued for approx. 3 days.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Syncope after receiving Tdap and MENACTRA Vaccines.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Mild (<50 lesions) rash consistent with varicella.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Fall, Tremor
Clinical narrative: Walking out the office mom states she fell and started shaking.
Age: 1.26
Sex: M
Vaccine: DTAP
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis around immunization site.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Feeling of body temperature change, Injection site pain, Nausea, Nervousness
Clinical narrative: Employee reported to the facility management that she felt nauseous, but that she ate and felt a little better afterward. She felt hot and cold flashes (more hot than cold), soreness around injection site, and feeling shaky. Oral temp, 98.1. BP, 118/77. Pulse, 63.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Acupuncture, Blood test normal, Computerised tomogram, Cow's milk intolerance
Clinical narrative: Muscle Spasm began in legs soon after vaccination. Spasm increased in strength and progressed to other areas of body. Treatment sought with Pediatrician. Over a period of 9 weeks the pain became intolerable and she was brought to hospital ER. After no cause found in blood work & tests we took her to 2 Neurologists & then a Rheumatologist. Doctors felt that this could be a side effect of vaccination or a post viral syndrome brought on by the vaccine. Slowly over many months the muscle spasm improved but at the same time she developed gastrointestinal spasm. She has been treated by two gastroenterologists. The consensus is the muscular spasm migrated to her GI Tract. She now has chronic gastrointestinal problems along with severe gluten & dairy sensitivity. Over the course of almost three years, she has endured pain, fatigue, irregular heart beat, weight loss, abdominal pain, dietary problems.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Echocardiogram, Electromyogram, Fatigue, Gastrointestinal disorder, Gastrointestinal pain
Clinical narrative: Muscle Spasm began in legs soon after vaccination. Spasm increased in strength and progressed to other areas of body. Treatment sought with Pediatrician. Over a period of 9 weeks the pain became intolerable and she was brought to hospital ER. After no cause found in blood work & tests we took her to 2 Neurologists & then a Rheumatologist. Doctors felt that this could be a side effect of vaccination or a post viral syndrome brought on by the vaccine. Slowly over many months the muscle spasm improved but at the same time she developed gastrointestinal spasm. She has been treated by two gastroenterologists. The consensus is the muscular spasm migrated to her GI Tract. She now has chronic gastrointestinal problems along with severe gluten & dairy sensitivity. Over the course of almost three years, she has endured pain, fatigue, irregular heart beat, weight loss, abdominal pain, dietary problems.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Gluten sensitivity, Heart rate irregular, Laboratory test normal, Muscle spasms, Nuclear magnetic resonance imaging
Clinical narrative: Muscle Spasm began in legs soon after vaccination. Spasm increased in strength and progressed to other areas of body. Treatment sought with Pediatrician. Over a period of 9 weeks the pain became intolerable and she was brought to hospital ER. After no cause found in blood work & tests we took her to 2 Neurologists & then a Rheumatologist. Doctors felt that this could be a side effect of vaccination or a post viral syndrome brought on by the vaccine. Slowly over many months the muscle spasm improved but at the same time she developed gastrointestinal spasm. She has been treated by two gastroenterologists. The consensus is the muscular spasm migrated to her GI Tract. She now has chronic gastrointestinal problems along with severe gluten & dairy sensitivity. Over the course of almost three years, she has endured pain, fatigue, irregular heart beat, weight loss, abdominal pain, dietary problems.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Ultrasound pelvis, Weight decreased
Clinical narrative: Muscle Spasm began in legs soon after vaccination. Spasm increased in strength and progressed to other areas of body. Treatment sought with Pediatrician. Over a period of 9 weeks the pain became intolerable and she was brought to hospital ER. After no cause found in blood work & tests we took her to 2 Neurologists & then a Rheumatologist. Doctors felt that this could be a side effect of vaccination or a post viral syndrome brought on by the vaccine. Slowly over many months the muscle spasm improved but at the same time she developed gastrointestinal spasm. She has been treated by two gastroenterologists. The consensus is the muscular spasm migrated to her GI Tract. She now has chronic gastrointestinal problems along with severe gluten & dairy sensitivity. Over the course of almost three years, she has endured pain, fatigue, irregular heart beat, weight loss, abdominal pain, dietary problems.
Age: 65.0
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site mass, Vaccination site swelling
Clinical narrative: Patient came to pharmacy presenting with redness, swelling, lump on the left arm where vaccine was given. Patient says it started to happen a few days after the vaccine was given.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: Small rash appearing approximately 24 hours post administration. Patient describes rash as initially warm to the touch but was not warm on the day that patient returned to pharmacy. Rash is approximately 1 inch by 2.5 inches in size. Patient denies fever, pain, aches, or dizziness. Patient states that she applied some lotion (unclear what type) to the rash and it feels better. Patient appears to otherwise be in good health and not under distress and did not seek further medical treatment.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a(n) Health Professional and concerns a(n) 61 years old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On an unknown date, after starting/treatment with AFLURIA the patient experienced sore muscle (non serious, outcome: unknown). For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Linked case: 2016059680 (same patient).
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous case was initially received on 14-Mar-2016. The case report was received from a(n) Non Health Professional and concerns a(n) patient with unknown age and gender. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received an Unspecified flu vaccine on unknown dates, Batch no: not provided, Route of administration: Intramuscular, Dose: no information provided. Additional suspect drug(s): On an unspecified date, the patient received ZOSTAVAX, Batch number not provided. Reaction(s)/event(s) and outcome: On an unknown date about two weeks later, after starting / treatment with Unspecified flu vaccine and ZOSTAVAX, the patient presented to the doctor's office with what appeared to look like shingles. The shingles-like rash spread over the arm, torso, and on the lower chest; the rash looked like vesicular lesions with no particular dermatome (non serious, outcome: Unknown). Reporter's assessment: Non-serious. Case corrections (2-Mar-2016): AE 1 (LLT: skin lesions) was deleted.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: This health authority case was initially received on 22-Feb-2016. The case report was received from a(n) Health Professional and concerns a(n) female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): On an unspecified date, the patient received (2014) influenza vaccine. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: In 2014, after starting / treatment with (2014) influenza vaccine the patient experienced arm swollen (non serious, outcome: unknown), low grade fever (non serious, outcome: unknown). For relevant test results see appropriate report section. Linked case: 2016060151 (same patient).
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a(n) Health Professional and concerns a(n) female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report section. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received Influenza vaccine. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On an unknown date, after starting / treatment with Flu shots the patient experienced Soreness (non serious, outcome: Unknown). For relevant test results see appropriate report section. Linked case: 2016060274 (same patient).
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Influenza
Clinical narrative: This spontaneous consumer report (initial receipt 08-Sep-2015) concerns a female patient. On an unspecified date in Nov-2014, the patient received an unspecified influenza vaccine (manufacturer and batch number not provided). On an unspecified date during summer 2015, the patient experienced influenza. No further information provided. The outcome was not reported.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: This spontaneous consumer report (initial receipt 08-Sep-2015) concerns a female patient. On an unspecified date in Nov-2014, the patient received an unspecified influenza vaccine (manufacturer and batch number not provided). On an unspecified date during summer 2015, the patient experienced influenza. No further information provided. The outcome was not reported.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Adverse event
Clinical narrative: The case report was received from a (n) Health Professional and concerns a (n) 50 year old female patient. Linked Case ID (s): US-BEH-2016058697 (Same patient). Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received an Influenza (seasonal) vaccine for indication not reported in Sep-2015, Batch no: not provided, Route of administration: Unknown, Dose: Unknown. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/event (s) and outcome: On an unknown date, after starting/ treatment with Influenza (seasonal) vaccine the patient experienced an Adverse event (non serious, outcome: Unknown). Reporter's assessment: Not reported. Company's evaluation and comment: Seriousness criterion/criteria: Non serious. Listedness: According to the Reference Safety Information, the event Adverse event is a unlisted event of Influenza (seasonal) vaccine. Case Causality: Unassessable/unclassifiable due to insufficient information.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Axillary pain, Influenza, Injected limb mobility decreased, Lymphadenopathy, Malaise
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Dec-2015) concerns a 38.5 year old female patient. On an unspecified date in 2014, the patient received influenza vaccine (manufacturer and batch number not reported) in the right arm. On an unspecified date, about a week after the injection, the patient experienced malaise, low grade fever, pain under her right arm, in the neck and the clavicular area. She noticed several pea sized swollen lymph nodes in the clavicular area and neck. She could hardly raise her right arm and it was painful to turn her neck. The reactions were not as severe. The symptoms lasted about 2 weeks. In Jan-2015, she did get the flu. The outcome was reported as unknown. Linked case: 2016059814 (same patient).
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Neck pain, Pain, Pyrexia
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Dec-2015) concerns a 38.5 year old female patient. On an unspecified date in 2014, the patient received influenza vaccine (manufacturer and batch number not reported) in the right arm. On an unspecified date, about a week after the injection, the patient experienced malaise, low grade fever, pain under her right arm, in the neck and the clavicular area. She noticed several pea sized swollen lymph nodes in the clavicular area and neck. She could hardly raise her right arm and it was painful to turn her neck. The reactions were not as severe. The symptoms lasted about 2 weeks. In Jan-2015, she did get the flu. The outcome was reported as unknown. Linked case: 2016059814 (same patient).
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Dyspnoea, Eye pruritus, Ocular hyperaemia, Wheezing
Clinical narrative: This medically confirmed literature case (initial receipt 16-Dec-2015) concerns a 55 year old female patient. The author identified confirmed cases of anaphylaxis from the Vaccine Safety Datalink from vaccination records from January 2009 through December 2011. The patient had no history of atopy. On an unspecified date between 01-Jan-2009 through 31-Dec-2011, the patient received influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, 6 hours after vaccination, the patient experienced anaphylaxis. The symptoms included wheeze, shortness of breath and red and itchy eyes. The case met Brighton Collaboration case definition of anaphylaxis criteria level 2. She received treatment with oral antihistamines, oral steroids, bronchodilators and fluids and rest. The outcome was recovered and was referred to PCP (primary care physician). Reporter's comments: The attributed trigger was vaccine.
Age: 6.0
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Cough, Pharyngeal erythema, Pruritus generalised, Rash
Clinical narrative: This medically confirmed literature case (initial receipt 16-Dec-2015) concerns a 6 year old female patient. The author identified confirmed cases of anaphylaxis from the Vaccine Safety Datalink from vaccination records from January 2009 through December 2011. The patient had medical history of atopy: anaphylaxis, allergic rhinitis, reactive airway disease and 'other (TIV)'. On an unspecified date between 01-Jan-2009 through 31-Dec-2011, the patient received influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, between 60 to less than 90 minutes after 5 test doses vaccine, the patient experienced anaphylaxis. The symptoms included erythema (throat), generalized pruritus and rash and cough. The case met Brighton Collaboration case definition of anaphylaxis criteria level 2. She received treatment with epinephrine and oral antihistamine. The outcome was reported as recovered. Reporter's comments: The attributed trigger was vaccine.
Age: 44.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Facial paralysis
Clinical narrative: This medically confirmed health authority report (initial receipt 22-Feb-2016) concerns a 44 year old male patient. The patient had medical history of sulfa allergy. On an unspecified date, the patient received influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, three months after vaccination, the patient experienced Bell's palsy. The outcome was not reported. Linked case: 2016059359 (same patient).
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Dyspnoea, Pruritus generalised, Swollen tongue, Throat tightness
Clinical narrative: This medically confirmed literature case (initial receipt 16-Dec-2015) concerns a 35 year old female patient. The author identified confirmed cases of anaphylaxis from the Vaccine Safety Datalink from vaccination records from January 2009 through December 2011. The patient had history atopy: other (shell fish, latex, amoxicillin, ciprofloxacin and gentamycin). On an unspecified date between 01-Jan-2009 through 31-Dec-2011, the patient received influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, in less than 30 minutes after vaccination, the patient experienced anaphylaxis. The symptoms included generalized pruritus, swelling (tongue), shortness of breath (SOB) and throat closure. The case met Brighton Collaboration case definition of anaphylaxis criteria level 2. She received treatment with epinephrine, parenteral antihistamine, IVT (intravenous transfusion) and bronchodilator (albuterol). The outcome was recovered. Reporter's comments: The attributed trigger was vaccine. ***Case correction (12-Jan-2016): Upgraded all events to serious.
Age: 27.0
Sex: F
Vaccine: FLUX, FLUX(H1N1), FLUX, FLUX(H1N1)
Symptoms: Anaphylactic reaction, Chest discomfort, Eye pruritus, Generalised erythema, Heart rate increased
Clinical narrative: This medically confirmed literature case (initial receipt 16-Dec-2015) concerns a 27 year old female patient. The author identified confirmed cases of anaphylaxis from the Vaccine Safety Datalink from vaccination records from January 2009 through December 2011. The patient had no history of atopy. On an unspecified date between 01-Jan-2009 through 31-Dec-2011, the patient received Influenza virus vaccine (manufacturer and batch number not reported) and H1N1 (manufacturer and batch number not reported). On an unspecified date, 2 hours after vaccination, the patient experienced anaphylaxis. The symptoms included generalized erythema and rash, red itchy eyes, increased heart rate, palpitations, swelling (throat) and chest heaviness. The case met Brighton Collaboration case definition of anaphylaxis criteria level 1. She received treatment with oral antihistamines and acetaminophen. The outcome was recovered. The patient was referred to PCP (primary care physician). Linked case: 2015057134 (same patient). Reporter's comments: The attributed trigger was vaccine.
Age: 27.0
Sex: F
Vaccine: FLUX, FLUX(H1N1), FLUX, FLUX(H1N1)
Symptoms: Ocular hyperaemia, Palpitations, Pharyngeal oedema, Rash
Clinical narrative: This medically confirmed literature case (initial receipt 16-Dec-2015) concerns a 27 year old female patient. The author identified confirmed cases of anaphylaxis from the Vaccine Safety Datalink from vaccination records from January 2009 through December 2011. The patient had no history of atopy. On an unspecified date between 01-Jan-2009 through 31-Dec-2011, the patient received Influenza virus vaccine (manufacturer and batch number not reported) and H1N1 (manufacturer and batch number not reported). On an unspecified date, 2 hours after vaccination, the patient experienced anaphylaxis. The symptoms included generalized erythema and rash, red itchy eyes, increased heart rate, palpitations, swelling (throat) and chest heaviness. The case met Brighton Collaboration case definition of anaphylaxis criteria level 1. She received treatment with oral antihistamines and acetaminophen. The outcome was recovered. The patient was referred to PCP (primary care physician). Linked case: 2015057134 (same patient). Reporter's comments: The attributed trigger was vaccine.