chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Treponema test negative, Viral load decreased
Clinical narrative: This medically confirmed literature report (initial receipt 22-Jul-2014) concerns a 46-year-old female patient who had a medical history of human immunodeficiency virus (HIV) disease. Her concomitant medications included efavirenz, lamivudine and zidovudine. She noted no history of previous reaction to drugs or vaccinations of any kind. She had received annual influenza vaccines in the past without incident. On an unknown date, she received influenza vaccine (manufacturer and batch number not provided) for her annual influenza vaccination. On an unknown date, one day following the influenza vaccination, she developed a rash. On an unknown date, she presented at the clinic with seven weeks of onset of a diffuse, highly pruritic rash. On physical examination, she had a diffuse eruption of hyperpigmented, slightly violaceous polygonal papules and plaques with white, lacy reticulations that spared her face, palms, and soles. No changes were noted on the buccal mucosa. The CD4 count one month prior to vaccination was normal at 704 cells/mcL. The viral load was suppressed at 128 copies/nL. Histopathology revealed a lichenoid interface dermatitis with eosinophils, most consistent with lichenoid drug eruption. Immunohistochemical stain for Treponema pallidum was negative. She was treated with high potency topical corticosteroids, two oral prednisone tapes, and narrow band UVB therapy. While therapy was being initiated, the lesions progressed to include the face. Narrow band UVB therapy and clobetasol ointment were continued, and metronidazole 500mg PO BID and topical tacrolimus 0.1% ointment were added to the regimen. Approximately 6 months after initiating therapy, all active lesions had resolved with marked post-inflammatory hyperpigmentation. Outcome was reported as recovered for all active lesions, and unknown for other symptoms. Author's comments: Lichenoid drug reactions to vaccinations are rare but well-documented events, vast majority of these reported reactions have been triggered by Hepatitis B vaccination. This is only the fifth reported case of lichenoid drug reaction, and only the second generalized case, following influenza vaccination. The patient's underlying HIV disease, known to be a risk factor for both cutaneous drug reactions and more severe manifestations of lichen planus, likely predisposed her to this generalized hypersensitivity phenomenon.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Discomfort, Erythema
Clinical narrative: Redness and mild discomfort.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Swelling in upper left shoulder site is warm to touch and redden patient complains of pain.
Age: 0.38
Sex: M
Vaccine: DTAPIPV, HIBV, PNC, RV5
Symptoms: Injection site erythema, Injection site vesicles, Injection site warmth
Clinical narrative: Blisters at site of injection/ Redness and fever at site if of injection.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood test, Decreased appetite, Irritability, Pyrexia, Vomiting
Clinical narrative: Fever, vomiting, irritability, did not eat for 27hours, hospitalized- fluids and blood work.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Balance disorder, Computerised tomogram, Dysarthria, Electroencephalogram, Headache
Clinical narrative: Problem w/ balance, slurred speech, headache, muscle weakness, dysarthria.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging
Clinical narrative: Problem w/ balance, slurred speech, headache, muscle weakness, dysarthria.
Sex: U
Vaccine: UNK
Symptoms: Laboratory test abnormal, Malaise, Pertussis, Polymerase chain reaction
Clinical narrative: Initial case received from a physician on 29 July 2014. Numerous patients (ages and genders not reported) were diagnosed with pertussis within one year of receiving the fourth dose of either ADACEL, DAPTACEL, or PENTACEL. According to the reporter, the patients were mildly ill at the time of testing, and all tested positive on PCR. Past medical history, dates of administration, lot numbers, treatment, and outcome were not reported. The events had also been reported to the State health department. No additional information was provided. Documents held by sender: None.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Corneal abrasion, Diarrhoea, Eye inflammation, Eye pruritus, Fatigue
Clinical narrative: Initial case received from a consumer on 28 July 2014. A 49-year old female patient had received an intramuscular dose of ADACEL (batch number U4612AA, expiry date 20 September 2015) in the arm on 14 June 2013. She had a medical history of allergies to latex, amoxicillin, LEVAQUIN, mycin's and tomatoes. She has also a piece of metal in her head. On 14 June 2013, immediately after she received the vaccine, she experienced itchy eyes, lips swelled, flu-like symptoms, severe headache, and diarrhea. She felt tired, went to bed and slept 16 hours. She also developed otitis media, sinusitis, inflammation of her eyes, scratched cornea, "systematic inflammation" and vertigo problems on unspecified dates. She reported that she has had ongoing problems since vaccination. She had been evaluated in a clinic and by a neurologist. No information concerning concomitant therapies, complementary investigations or corrective treatment was provided. Outcome was reported as unknown. Document held by sender: none.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Hypersomnia, Immediate post-injection reaction, Inflammation, Influenza like illness
Clinical narrative: Initial case received from a consumer on 28 July 2014. A 49-year old female patient had received an intramuscular dose of ADACEL (batch number U4612AA, expiry date 20 September 2015) in the arm on 14 June 2013. She had a medical history of allergies to latex, amoxicillin, LEVAQUIN, mycin's and tomatoes. She has also a piece of metal in her head. On 14 June 2013, immediately after she received the vaccine, she experienced itchy eyes, lips swelled, flu-like symptoms, severe headache, and diarrhea. She felt tired, went to bed and slept 16 hours. She also developed otitis media, sinusitis, inflammation of her eyes, scratched cornea, "systematic inflammation" and vertigo problems on unspecified dates. She reported that she has had ongoing problems since vaccination. She had been evaluated in a clinic and by a neurologist. No information concerning concomitant therapies, complementary investigations or corrective treatment was provided. Outcome was reported as unknown. Document held by sender: none.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Lip swelling, Otitis media, Sinusitis, Systemic inflammatory response syndrome, Vertigo
Clinical narrative: Initial case received from a consumer on 28 July 2014. A 49-year old female patient had received an intramuscular dose of ADACEL (batch number U4612AA, expiry date 20 September 2015) in the arm on 14 June 2013. She had a medical history of allergies to latex, amoxicillin, LEVAQUIN, mycin's and tomatoes. She has also a piece of metal in her head. On 14 June 2013, immediately after she received the vaccine, she experienced itchy eyes, lips swelled, flu-like symptoms, severe headache, and diarrhea. She felt tired, went to bed and slept 16 hours. She also developed otitis media, sinusitis, inflammation of her eyes, scratched cornea, "systematic inflammation" and vertigo problems on unspecified dates. She reported that she has had ongoing problems since vaccination. She had been evaluated in a clinic and by a neurologist. No information concerning concomitant therapies, complementary investigations or corrective treatment was provided. Outcome was reported as unknown. Document held by sender: none.
Age: 16.0
Sex: M
Vaccine: TDAP
Symptoms: Blindness, Deafness, Heart rate decreased, Presyncope, Skin discolouration
Clinical narrative: Mom reports on way home after receiving Tdap patient became "gray" looking, had a loss of hearing and vision with decrease heart rate. Took patient to ER was diagnosed with syncopal episode and vagal response. Mom reports patient was given 2 Liters of IVF and sent home.
Age: 16.0
Sex: M
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Mom reports on way home after receiving Tdap patient became "gray" looking, had a loss of hearing and vision with decrease heart rate. Took patient to ER was diagnosed with syncopal episode and vagal response. Mom reports patient was given 2 Liters of IVF and sent home.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site induration, Vaccination site swelling
Clinical narrative: Immunization site became red, swollen, hard and itchy.  Hydrocortisone cream 1% and ice were applied.
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Bronchitis, Chronic obstructive pulmonary disease, Condition aggravated, Dyspnoea, Injected limb mobility decreased
Clinical narrative: This case was reported by a consumer (patient) during GSK market research and described the occurrence of difficulty breathing in a female patient who received ADVAIR unspecified inhaler device for chronic obstructive pulmonary disease. A physician or other health care professional has not verified this report. Concurrent medical conditions included chronic obstructive pulmonary disease. Co-suspect medication included Albuterol. On an unknown date, the patient started Fluticasone propionate+salmeterol xinafoate and Salbutamol sulphate (unknown), unknown dosing. At an unknown time after starting Fluticasone propionate+salmeterol xinafoate, the patient experienced, "I need some help with my breathing". At the time of reporting, the outcome of the event was unknown. Follow-up information received on 21 October 2013 from a consumer via a market research program. Co-suspect medications included Influenza vaccine unspecified and Pneumonia vaccine (Non-GSK) received in October 2013 and less than a week after vaccination with Influenza vaccine unspecified and Pneumonia vaccine (Non-GSK) in October 2013, the patient experienced injection site movement impairment and didn't sleep. The patient said in a conversation online: "I got my flu shot and pneumonia shot in the same day last week. One in my left arm, the other in my right. Don't know which was which but I do know I could hardly move my right arm. Didn't sleep for 2 nights." Follow-up information was received on 30 December 2013 via consumer who reported "I had no problems with ADVAIR when I got my flu shot". At the time of the report no other information was provided. The consumer declined to provide authorization to contact physician. Follow-up information was received on 04 January 2014 via market research program. The patient developed bronchitis on unknown date in 2013 (sometime around Thanksgiving and Christmas). No further information provided. No further information will be sought since patient had denied permission prior to this report. Follow-up information was received on 28 July 2014 via market research program. The patient reported "my last COPD (chronic obstructive pulmonary disease) check up was scheduled for 13 June of last year (2013)...my other doctors are concerned that my lungs are worsening and are stressing about getting to my Pulmonologist. He is located in the next town (none in my town) and I can't get there". The patient reported she was trying to "coordinate a visit that is so badly needed. I was supposed to have a CT (computed tomography) and MRI (magnetic resonance image) the first part of this month (every three months) for my cancer and that isn't done either so will have to work on that as well." No further information provided. At the time of the report the outcome of exacerbation of COPD and cancer was unknown.
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Insomnia, Lung disorder, Neoplasm malignant
Clinical narrative: This case was reported by a consumer (patient) during GSK market research and described the occurrence of difficulty breathing in a female patient who received ADVAIR unspecified inhaler device for chronic obstructive pulmonary disease. A physician or other health care professional has not verified this report. Concurrent medical conditions included chronic obstructive pulmonary disease. Co-suspect medication included Albuterol. On an unknown date, the patient started Fluticasone propionate+salmeterol xinafoate and Salbutamol sulphate (unknown), unknown dosing. At an unknown time after starting Fluticasone propionate+salmeterol xinafoate, the patient experienced, "I need some help with my breathing". At the time of reporting, the outcome of the event was unknown. Follow-up information received on 21 October 2013 from a consumer via a market research program. Co-suspect medications included Influenza vaccine unspecified and Pneumonia vaccine (Non-GSK) received in October 2013 and less than a week after vaccination with Influenza vaccine unspecified and Pneumonia vaccine (Non-GSK) in October 2013, the patient experienced injection site movement impairment and didn't sleep. The patient said in a conversation online: "I got my flu shot and pneumonia shot in the same day last week. One in my left arm, the other in my right. Don't know which was which but I do know I could hardly move my right arm. Didn't sleep for 2 nights." Follow-up information was received on 30 December 2013 via consumer who reported "I had no problems with ADVAIR when I got my flu shot". At the time of the report no other information was provided. The consumer declined to provide authorization to contact physician. Follow-up information was received on 04 January 2014 via market research program. The patient developed bronchitis on unknown date in 2013 (sometime around Thanksgiving and Christmas). No further information provided. No further information will be sought since patient had denied permission prior to this report. Follow-up information was received on 28 July 2014 via market research program. The patient reported "my last COPD (chronic obstructive pulmonary disease) check up was scheduled for 13 June of last year (2013)...my other doctors are concerned that my lungs are worsening and are stressing about getting to my Pulmonologist. He is located in the next town (none in my town) and I can't get there". The patient reported she was trying to "coordinate a visit that is so badly needed. I was supposed to have a CT (computed tomography) and MRI (magnetic resonance image) the first part of this month (every three months) for my cancer and that isn't done either so will have to work on that as well." No further information provided. At the time of the report the outcome of exacerbation of COPD and cancer was unknown.
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Insomnia
Clinical narrative: This case was reported by a consumer (patient) during GSK market research and described the occurrence of difficulty breathing in a female patient who received ADVAIR unspecified inhaler device for chronic obstructive pulmonary disease. A physician or other health care professional has not verified this report. Concurrent medical conditions included chronic obstructive pulmonary disease. Co-suspect medication included Albuterol. On an unknown date, the patient started Fluticasone propionate+salmeterol xinafoate and Salbutamol sulphate (unknown), unknown dosing. At an unknown time after starting Fluticasone propionate+salmeterol xinafoate, the patient experienced, "I need some help with my breathing". At the time of reporting, the outcome of the event was unknown. Follow-up information received on 21 October 2013 from a consumer via a market research program. Co-suspect medications included Influenza vaccine unspecified and Pneumonia vaccine (Non-GSK) received in October 2013 and less than a week after vaccination with Influenza vaccine unspecified and Pneumonia vaccine (Non-GSK) in October 2013, the patient experienced injection site movement impairment and didn't sleep. The patient said in a conversation online: "I got my flu shot and pneumonia shot in the same day last week. One in my left arm, the other in my right. Don't know which was which but I do know I could hardly move my right arm. Didn't sleep for 2 nights." Follow-up information was received on 30 December 2013 via consumer who reported "I had no problems with ADVAIR when I got my flu shot". At the time of the report no other information was provided. The consumer declined to provide authorization to contact physician. Follow-up information was received on 04 January 2014 via market research program. The patient developed bronchitis on unknown date in 2013 (sometime around Thanksgiving and Christmas). No further information provided. No further information will be sought since patient had denied permission prior to this report. Follow-up information was received on 28 July 2014 via market research program. The patient reported "my last COPD (chronic obstructive pulmonary disease) check up was scheduled for 13 June of last year (2013)...my other doctors are concerned that my lungs are worsening and are stressing about getting to my Pulmonologist. He is located in the next town (none in my town) and I can't get there". The patient reported she was trying to "coordinate a visit that is so badly needed. I was supposed to have a CT (computed tomography) and MRI (magnetic resonance image) the first part of this month (every three months) for my cancer and that isn't done either so will have to work on that as well." No further information provided. At the time of the report the outcome of exacerbation of COPD and cancer was unknown.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Blood culture negative, Body temperature increased, Cellulitis, Injection site erythema, Injection site induration
Clinical narrative: This spontaneous report as received from a physician refers to a 70 year old female patient with penicillin allergy and chronic obstructive pulmonary disease (COPD). The patient's medical history included coronary artery bypass in May 2014. On 25-JUN-2014 the patient was vaccinated with PNEUMOVAX 23 lot # J004080, expiration date 22-AUG-2014, 0.5 ml, intramuscular in the left deltoid (dose number was not reported). Concomitant therapies included SPIRIVA, ADVAIR, PLAVIX, ZOCOR, verapamil, LASIX, metoprolol, lisinopril (manufacturer unknown) and potassium supplements (unspecified). After receiving the vaccine, on approximately 25-JUN-2014, the patient experienced arm being tender, with redness, swelling and induration at the injection site. The patient went to emergency room and was hospitalized on 27-JUN-2014 to 01-JUL-2014 with cellulitis. During hospital stay, the patient experienced temperature of 102.9F and white blood cell count was 25100 (units not reported). The treatment given to the patient included vancomycin and LEVAQUIN. The outcome of cellulitis was reported as recovering/resolving (also reported as patient experienced clinical improvement over 48 hours). The relationship between PNEUMOVAX 23 and the event was not reported. Physician requested lot check on PNEUMOVAX 23 lot # J004080, expiration date 22-AUG-2014. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Tenderness, White blood cell count increased
Clinical narrative: This spontaneous report as received from a physician refers to a 70 year old female patient with penicillin allergy and chronic obstructive pulmonary disease (COPD). The patient's medical history included coronary artery bypass in May 2014. On 25-JUN-2014 the patient was vaccinated with PNEUMOVAX 23 lot # J004080, expiration date 22-AUG-2014, 0.5 ml, intramuscular in the left deltoid (dose number was not reported). Concomitant therapies included SPIRIVA, ADVAIR, PLAVIX, ZOCOR, verapamil, LASIX, metoprolol, lisinopril (manufacturer unknown) and potassium supplements (unspecified). After receiving the vaccine, on approximately 25-JUN-2014, the patient experienced arm being tender, with redness, swelling and induration at the injection site. The patient went to emergency room and was hospitalized on 27-JUN-2014 to 01-JUL-2014 with cellulitis. During hospital stay, the patient experienced temperature of 102.9F and white blood cell count was 25100 (units not reported). The treatment given to the patient included vancomycin and LEVAQUIN. The outcome of cellulitis was reported as recovering/resolving (also reported as patient experienced clinical improvement over 48 hours). The relationship between PNEUMOVAX 23 and the event was not reported. Physician requested lot check on PNEUMOVAX 23 lot # J004080, expiration date 22-AUG-2014. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: HEP
Symptoms: Anger, Dissociation, Disturbance in attention, Electroencephalogram normal, Emotional disorder
Clinical narrative: The pt reports that he received HepB #1 vaccine on 18 April 2014, about 20-30 mins following vaccination he was walking in hospital and started feeling "out of body" but was still walking and communicating. He got home and this feeling transitioned into a headache. He says the headache was intense for 3 days and slowly tapered off for several days. He also reports that during the time he started feeling increased irritability, anger, decreased concentration and decreased emotion/caring/libido. These feeling lasted for 3-4 weeks. He reports he is back to his baseline.
Age: 42.0
Sex: M
Vaccine: HEP
Symptoms: Headache, Irritability, Libido decreased, Nuclear magnetic resonance imaging normal
Clinical narrative: The pt reports that he received HepB #1 vaccine on 18 April 2014, about 20-30 mins following vaccination he was walking in hospital and started feeling "out of body" but was still walking and communicating. He got home and this feeling transitioned into a headache. He says the headache was intense for 3 days and slowly tapered off for several days. He also reports that during the time he started feeling increased irritability, anger, decreased concentration and decreased emotion/caring/libido. These feeling lasted for 3-4 weeks. He reports he is back to his baseline.
Sex: U
Vaccine: HEPA, MMRV
Symptoms: Abnormal behaviour, Ataxia, Irritability
Clinical narrative: Irritable and triggered behavior 2-3d followed by ataxia x1 month.
Age: 12.0
Sex: M
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: DTAP given instead of TDAP. PC to mother to inform - will need Tdap - in 6 months ok for school till then. Public Health Nurse informed.
Age: 0.35
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 3cm erythema swelling of injection site of PREVNAR.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Fatigue, Feeling hot, Headache, Malaise
Clinical narrative: 7-30-14 received vaccine about 30 mins later started to feel tired. 8-1-14 has a bad H/A, "legs feel heavy". Feels like she is hot. Feels sick, nauseated, no vomiting, weakness, achy pain legs, vision feeling. No pain at injection site.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Pain in extremity, Sensation of heaviness, Visual impairment
Clinical narrative: 7-30-14 received vaccine about 30 mins later started to feel tired. 8-1-14 has a bad H/A, "legs feel heavy". Feels like she is hot. Feels sick, nauseated, no vomiting, weakness, achy pain legs, vision feeling. No pain at injection site.
Age: 17.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 17 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 19-JUN-2014 the patient was vaccinated with second dose of VAQTA (dose, frequency and route of administration were not reported) (lot # J011385, expiry date: 10-MAR-2016) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for VAQTA. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link). Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: MMR
Symptoms: Abnormal behaviour, Irritability, Pyrexia, Screaming
Clinical narrative: She woke up with 102.2 fever.  She has had a fever for 4 days now.  Her behavior has changed, even with Advil or Tylenol to keep the fever down, she has been screaming at night and fussy during the day.  She was previously a happy baby who has never been sick.
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Child received 2nd dose of Pediarix, Prevnar13, hib & Rotateq 3 weeks after first dose.
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Child received 2nd dose of Pediarix, Prevnar13, hib & Rotateq 3 weeks after first dose.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (reported also as a Certified Medical Assistant) refers to a female patient of unknown age. On 06-FEB-2013 the patient was vaccinated with a first dose of GARDASIL injection (lot # and expiration date not provided) (dose: 0.5ml), intramuscular (IM). On 08-APR-2013 the patient was vaccinated with a second dose of GARDASIL (lot # and expiration date not provided) (dose: 0.5ml), intramuscularly (IM) and on 21-JUL-2014, reported as today, the patient would received the third dose of GARDASIL (lot # and expiration date not provided) (dose: 0.5ml), intramuscularly (IM). No adverse effect reported. Additional information has been requested.
Age: 0.7
Sex: F
Vaccine: RV5
Symptoms: Faeces discoloured
Clinical narrative: This spontaneous report as received from a medical assistant who refers to a 8 month old female patient. On an unknown date, the patient was vaccinated with ROTATEQ (dose 3, frequency: two months intervals, orally). On an unknown date also reported as one week post vaccination after her third dose of ROTATEQ, the patient experienced one week of yellow stool. The patient did not experienced any vomiting, or fever. No treatment was given for adverse event. The patient did not seek medical attention. The outcome of yellow stool was reported as recovered/resolved. Relatedness between yellow stool and ROTATEQ was not reported. Additional information is not expected, as the reporter refused additional contact.
Age: 0.52
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information has been received from the registered nurse who provided patient details. This report refers to a 6 months old infant patient of unkown gender. On 12-JUN-2014 the patient was vaccinated with a dose of PEDVAXHIB (dose and route were not reported, lot# J015437, expiration date: 09-OCT-2016) that was improperly stored. No adverse effects were reported. This is the one of several reports received from the same reported. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a female consumer of unkonwn age refers to herself. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not provided). On an unknown date the patient was revaccinated with ZOSTAVAX because the initial dose may have been out of temperature storage range. No adverse effects were reported. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 13 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 15-JUL-2014 the patient was vaccinated with first dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # K005083, expiry date: 04-NOV-2016) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL.  This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918. 1407USA012919. 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407SUA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012939. 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959. 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989. 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012295, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link).  Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Hypoaesthesia, Myelitis, Palpitations
Clinical narrative: Numbness in left foot then gradually to my left arm and face.  Heart racing and hard to breathe.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: Fever, rash, crankiness.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Induration, redness, swelling and warmth at injection site.  Cellulitis treated with Keflex.
Age: 1.34
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Local swelling
Clinical narrative: Unsure of exact time of onset. Experienced significant swelling of thigh.  It had improved some, when parent called on 8/2/14.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Induration, redness, swelling, warmth at injection site.  Treated with Bactrim.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Blepharospasm
Clinical narrative: 2 days after vaccine eye twitching (continuous).
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Musculoskeletal stiffness, Pallor, Pyrexia, Staring
Clinical narrative: Child awakened from brief nap (2 pm) with non stop crying, fever (101.5), pale, stiff legs and eyes, staring simultaneously while crying.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Deafness, Pallor, Vision blurred
Clinical narrative: This 11 yr old girl received MENACTRA (MCV), HPV and Tdap IM at 3:30 PM. She looked pale and complained of blurry vision and hearing loss. BP was 77/42. HR 45/min. Epinephrine 0.5ml was given at 3:36 PM and again at 3:48 PM. Because of slow recovery the patient was transferred by ambulance to ER.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Fall, Head injury, Presyncope
Clinical narrative: Near syncopal episode. Pt. fell forward off of exam table, hitting head. Evaluated immediately by provider. BP 110/70 O2 Sat 99% P-62.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood glucose normal, Syncope
Clinical narrative: Fainting once for 1 min, came back and fainted again while EMT were trying to help him out. BP was 94/74, BS 88, EMT started IV, he was dehydrated after walking 4 mi and admitted to ER for one hour and released.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema migrans, Fatigue, Skin warm
Clinical narrative: Bull's eye rash, rash has continued to spread to most of upper arm, arm is hot to touch and compared to opposite arm much warmer in temp. Pt also reported feeling tired and joint pain day after receiving ZOSTAVAX.
Age: 50.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Erythema, Injection site bruising, Injection site pain, Injection site swelling, Joint swelling
Clinical narrative: Sore swelling arm from shoulder to fingertips with swollen red finger/joints lasting 1 week. Still bruised at site of injection.
Age: 50.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Local swelling, Pain in extremity
Clinical narrative: Sore swelling arm from shoulder to fingertips with swollen red finger/joints lasting 1 week. Still bruised at site of injection.
Age: 1.06
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Cough, Crying, Diarrhoea, Irritability, Nasal congestion
Clinical narrative: Crying/inconsolable/fussy for past 2 nights (3 days after vaccination), (+) nasal congestion and dry cough started 3 days after vaccinations. (+) diarrhea x 3 one day after vaccination.
Age: 4.0
Sex: U
Vaccine: DTAPIPV, MMRV
Symptoms: Lip swelling, Swelling face
Clinical narrative: Lower lip and chin swelled for about one hour then resolved itself. No meds given.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Eye movement disorder, Pallor
Clinical narrative: Came for PE - immunizations given with a few minutes eye rolled back - doctor called from next room - head place between legs then laid on floor with feet elevated - lasted approx 5-7 mins - color pale no SOB - had not eaten or drank anything since noon 7-28-14.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Induration, redness, swelling, warmth at injection site.  Treated with Bactrim.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Erythema, Headache, Local swelling
Clinical narrative: Pt came in for her yearly well child. Pt was due for her second HPV. Pt's mom said pt had a reaction to the previous shot - severe headaches, swelling and redness in the arm. "Mom said she laid on the couch x 5 days". Treated with rest and TYLENOL. Symptoms subsided (mom didn't think to call at the time). (Mom refused the 2nd HPV dose).
Age: 47.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: On 7/7/14 HCW reported redness to injection site. On 7-8-14 the redness and firmness measured 5ins by 5 ins and was painful. Evaluated by MD on site.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Tenderness
Clinical narrative: 2 areas on face are reddened and/or very sensitive to touch on arm following administration.
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Localized swelling, redness, heat at site. Baseball size area of swelling and redness x 3 days. Ice packs to area.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Erythematous indurated area on left deltoid started approx 24 hrs post meningococcal immunization. Improved 7/28/14, but still itchy w/sl. erythema.
Age: 24.0
Sex: M
Vaccine: TYP
Symptoms: Rash erythematous, Viral infection
Clinical narrative: After taking Vivotif Live Attenuated Typhoid vaccine, I developed a rose-colored rash across my back.  This rash has recurred every time I get a viral illness or am stress or sleep-deprived.  I am a physician.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash generalised
Clinical narrative: Full body skin rash with intense itching. Went to doctor on 8-4-14 and received steroid injection.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Hypotonia, Resuscitation, Vomiting
Clinical narrative: Mom reports vomited several times on 8-2-14. States baby was getting diaper change and vomited. States baby went limp. CPR started and ambulance was sent.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Dyskinesia, Pyrexia
Clinical narrative: 4:00 pm on 7/18/14 pt had fever 100.1 and developed "jerking" movements. Dr administered BENADRYL IV push in ER with pt completely symptom free in 2 hours.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site reaction, Pruritus, Skin lesion
Clinical narrative: 5cm x 6cm erythematous lesion w/o distinct borders tot he (R) thigh. No pain or streaking. Abx Rx given PRN worsening Sx. Antihistamine PRN itching.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Chills, Injection site erythema, Nausea, Pain in extremity
Clinical narrative: Pt c/o red, swollen LUE at vaccine site with fever, chills and nausea. Pt also c/o LUE pain. Dx: cellulitis.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Vaccination site swelling
Clinical narrative: Pt c/o red, swollen LUE at vaccine site with fever, chills and nausea. Pt also c/o LUE pain. Dx: cellulitis.
Age: 21.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Rash
Clinical narrative: Received rabies vaccine 6/10 and 6/17/14. Developed joint pain approx 6/19/14 and rash approx 6/21/14. Symptoms now resolved.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC13
Symptoms: Cough, Injection site pain, Irritability, Pyrexia, Urticaria
Clinical narrative: Snort like cough- dry/short/repetitive hours after vaccines. Fever 100 day after vaccines and leg pain c/w injection site soreness, Urticarial rash began 7/25/ evening and ongoing. Increased fussiness since afternoon of vaccines.
Age: 16.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a clinical/medical assistant refers to a 16 years old patient of unknown gender. On 23-JUN-2014 the patient was vaccinated with (Oka/Merck) PROQUAD (dose, lot # and expiry date were not reported) by mistake. No adverse effect was reported. Additional information is not expected because there is no consent to contact the reporter.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Swelling face, Urticaria
Clinical narrative: Developed hives on right arm, right side of neck and face and swelling on right side of face on 8/2/14 after MENVEO vaccine on 8/1/14 still present on 8/4/14.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker/medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date an unspecified number of patients were vaccinated with RECOMBIVAX HB (dose, frequency, lot#, expiry date and indication were not reported), which was stored improperly for a period of 25 days. No adverse effect was reported. This report is one of three linked reports from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Eye swelling
Clinical narrative: One eye swollen.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified patient of unknown age and gender. On 09-JUL-2014 the patient was vaccinated with the third dose of GARDASIL (route not reported). The patient had received the first two doses of GARDASIL 6 years earlier, in approximately 2008. No adverse events were reported. Additional information has been requested.
Age: 31.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain/swelling at injection site.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy, Neck pain, Pain in jaw
Clinical narrative: Mother noticed lymph nodes on her neck swollen on 7/19, with rt side of jaw pain, rt side of neck pain. On 7/25 was seen again by another doctor and was prescribed an antibiotic (AUGMENTIN).
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Eye swelling, Pruritus, Vomiting
Clinical narrative: Per mom, pts skin became redm and he started aching, eye swelled. Emesis x 1.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased
Clinical narrative: BP decrease. No LOC. 10:35, 108/72; 10:40, 92/58; 10:45, 80/52; 10:46, 88/54; 10:56, 90/62
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Dizziness, Fall, Muscle twitching, Unresponsive to stimuli
Clinical narrative: 5 minutes after receiving HPV, felt dizzy, unresponsive x 2-3 seconds. Started to fall and mother grabbed her. Rt arm was twitching for few seconds. Pulse and BP.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Redness at injection site. She's been using ice packs, IBUP for fever and starting BENADRYL. Spoke to her Dr and they said to continue this treatment.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to about 5 patients of unknown age and gender. On an unknown dates in July 2014, about 5 patients were vaccinated with PNEUMOVAX 23 (lot#, expiration date, dose not reported), intramuscular, that was improperly exposed to 35.06F for 72 hours (from 27-JUN-2014 until 30-JUN-2014). No known adverse effects were reported. Additional information has been requested.
Age: 1.04
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site haemorrhage, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 18 month old shots, varicella and MMR, caused painful bump on each leg. These bumps have not resolved and the patient will scratch them until they bleed.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 30-JUL-2014 the patient inadvertently received a dose of (Oka/Merck) VARIVAX (lot # unknown, 0.5 ml, subcutaneous) and a dose of (Oka/Merck) PROQUAD (lot #, strength, dosage and route). No symptoms reported. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unknown number of patients of unknown age and gender. It was reported that doses of VARIVAX (Merck) (lot #, dose and route not reported) that were improperly stored since an unspecified date in July 2014, had been administered to patients. No adverse events were reported. This is one of several reports from the same source. Additional information is not expected (reporter refused additional contact).
Age: 0.51
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 6 months old infant patient of unknown gender. On 11-JUN-2014 the patient was vaccinated with a dose of PEDVAXHIB (dose and route were not reported, lot# J015437, expiration date: 09-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with none pertinent medical history and none drug reactions or allergies. At the time of this report the patient was not pregnant. On 28-JUL-2014 the patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous, anatomical location, lot number were not reported). None concomitant medications were reported. On 30-JUL-2014, reported as "two days later", the patient experienced redness at the injection site. There was no treatment given for the adverse event. None lab diagnostics studies were performed. The patient did not seek medical attention. The outcome of redness at the injection site was reported as not recovered. The relatedness between redness at the injection site and ZOSTAVAX was not reported. Additional information is not expected because the reported do not wish to be contacted.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Pain in extremity, Rash erythematous
Clinical narrative: Pain in entire arm. Red rash and swelling at site of injection.
Sex: U
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: This spontaneous report as received from a medical assistant via a company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose, units, route of administration, anatomical location, lot number were not reported). The reporter stated that on an unknown date the patient because nauseous and dizzy after administration of GARDASIL. The outcome of nauseous and dizzy and relatedness between reported adverse events and GARDASIL were not reported. Additional information has been requested.