chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Gave an inadvertent (accidental) second dose of MMRV (PROQUAD), at about 10 AM on 8/19/14, that was meant for her twin. (Called Merck -> they are researching it via their medical team).
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 2 patients of unknown age and gender. On an unknown date the patients were vaccinated with doses of PNEUMOVAX 23 (dose and route of administration were not provided), which were exposed to temperatures outside of the proper storage ranges. No adverse effect reported. This is one of several  reports received from the same reporter. 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 nurse refers to a two unspecified patients of unknown age and gender. On 25-AUG-2014 the patients were vaccinated with an improperly stored dose of VARIVAX (merck) (strength, route, lot number and expiration date not reported). No adverse events were reported. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: On the next day, pt had redness, swelling at injection site and warmth - relieved with hydrocortisone cream and diphenhydramine.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a unspecified number of patients (1 or 2) of unknown age and gender. On an unknown date the patients were vaccinated with doses of ZOSTAVAX (vial; dose and route of administration were not provided), which were exposed to temperatures outside of the proper storage ranges. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash
Clinical narrative: Patient called pharmacy 8/25/14 complaining of swelling, redness and heat at injection site. Also, developing a rash on the wrist. She was advised to see her family physician.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient called pharmacy 8/25/14 complaining of swelling, redness and heat at injection site. Also, developing a rash on the wrist. She was advised to see her family physician.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Right arm red and swollen.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient has redness and swelling in left leg and it is warm at touch.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Swelling and itching at injection site. Swelling was significant.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling and itching at injection site. Swelling was significant.
Age: 0.56
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site rash, Irritability, Pyrexia, Rash, Vomiting
Clinical narrative: Fever 104.5, rash on legs and back, vomiting and fussy.
Age: 16.0
Sex: M
Vaccine: HEP, HEPA, HPV4, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Cough, Pyrexia, Respiratory tract congestion
Clinical narrative: Patient had fever, congestion, cough. Admitted to hospital.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Eye swelling
Clinical narrative: Swelling around eyes noted 15 mins after vaccinations when arrived home - no trouble breathing. Mom called ambulance - seen in ER about 30 mins after vaccines, no interventions needed sent home on BENADRYL and prednisolone.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Vomiting
Clinical narrative: Painful headache, vomiting lasting 2 hours.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Spontaneous penile erection
Clinical narrative: Patient/employee reported today (08/26/2014) that he concerned about receiving the influenza vaccine again this year because last year immediately after he received the vaccine, he experienced a penile erection that lasted approximately 3 minutes and then resolved on its own.
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Fatigue, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Burning and swelling at injection site, general malaise and fatigue, fever, stuffy nose, sneezing, and light headedness. Has continued from the morning 8am til now and still continues thus far.
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Nasal congestion, Pyrexia, Sneezing
Clinical narrative: Burning and swelling at injection site, general malaise and fatigue, fever, stuffy nose, sneezing, and light headedness. Has continued from the morning 8am til now and still continues thus far.
Age: 70.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Injection site erythema, Injection site oedema, Injection site pruritus, Oedema peripheral
Clinical narrative: Patient developed moderate edema/erythema and itching of her entire right arm after PNEUMOVAX on 8/21/14.
Age: 70.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pruritus
Clinical narrative: Patient developed moderate edema/erythema and itching of her entire right arm after PNEUMOVAX on 8/21/14.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Cellulitis, Erythema, Skin warm
Clinical narrative: Customer rec'd FLUVIRIN - LA and PNEUMOVAX - RA on 8/14/14. Shot was prepared with sterile technique as always. She reported on 8/16/14 pm that RA was hot, red 2" circle and had 103 degree temp on 8/15/14. By Sunday 8/17/14 red circle was 4"-5" around with no fever. Monday 8/18/14, she went to immediate care where she was prescribed doxycycline for cellulitis. No reaction to FLUVIRIN. Spoke with pt. 8/25/14 much better.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 79 year old male patient with aspirin allergy who had been hospitalized from unknown date and reason. On 17-AUG-2014 the patient was vaccinated with PNEUMOVAX 23 (dose, lot # and route of administration were not reported). There was not concomitant reaction. In August 204 the patient experienced redness, swelling, pain and hardness at the injection site. Some warm compresses were used as treatment for these reactions. There were not laboratory diagnostics studies performed. The reporter stated that the patient had been hospitalized prior to receiving PNEUMOVAX 23 therefore the hospitalization was not related to the adverse events. The outcome of redness, swelling, pain and hardness at the injection site was reported as not recovered/not resolved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age. No pertinent medical history or drug reactions/allergies were provided. The medical assistant reported that a patient received her first dose of GARDASIL on 20-AUG-2007, her second dose on 03-APR-2008, and her third dose on 03-JUN-2008 (dose, route and lot numbers were not specified). No adverse effect were reported. Additional information is not expected because there was no consent to follow-up.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Agitation, Lymphadenopathy, Pyrexia, Rash
Clinical narrative: This spontaneous report was received from a Healthcare worker concerning approximately a 4 year old female patient. The patient's medical history included anemia and gastrointestinal reflux disease. The patient had no drug reactions/allergies. On 07-AUG-2014 the patient was vaccinated with M-M-R II, lot # K002527, expiry date: 18-FEB-20166, 0.5 ml, once, subcutaneously. No concomitant therapy was reported. On 16-AUG-2014, the patient developed a rash on her arm, acting very agitated, fever of 103.5 and swollen glands and. The outcome of fever of 103.5 acting very agitated, swollen glands and developed a rash on her arm is unknown. No laboratory diagnostic tests were done. The patient sought medical attention. No intervention initiated to prevent serious criteria as there were none. On 16-AUG-2014, the patient was seen in the Urgent Care and saw physician on 19-AUG-2014. The Urgent Care physician ordered Cefdinir and Mupirocin to treat the symptoms. No product quality complaint was filed. The action taken was assessed as not applicable. The outcome and causality were not reported. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Oedema
Clinical narrative: Moderate edema 1 day post immunization. Recommended ice and ibuprofen/acetaminophen and monitor.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling, Pain
Clinical narrative: Patient had localized swelling and pain a few days after injection.  Received treatment from the physician.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Dizziness
Clinical narrative: After vaccination patient reported dizziness. Denied further symptoms. Given juice, observed. Patient left clinic walking with guardian, reported she was "ok".
Age: 32.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Arthralgia, Myalgia, Tendonitis, Vaccination site pain
Clinical narrative: Patient complaining of muscle and joint soreness and pain in the arm where the vaccines were given. Visited doctor on 08/26/2014 and was told it was tendonitis from the vaccines. Patient was given prednisone and told to take naproxen.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: C-reactive protein normal, Cytomegalovirus test negative, Full blood count normal, Irritability, Polymerase chain reaction
Clinical narrative: Fussiness, low grade fevers x 16 days.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia, Urine analysis normal
Clinical narrative: Fussiness, low grade fevers x 16 days.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching, hives.  Family gave her Allegra for several days.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Abdominal pain, Arthralgia, Blood bilirubin increased, Blood creatinine increased, Blood lactic acid increased
Clinical narrative: Shortness of breath, severe N/V/D, Sore throat, WBC 16.5. Slight redness at injection site-per RN at hospital.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: C-reactive protein increased, Chills, Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: Shortness of breath, severe N/V/D, Sore throat, WBC 16.5. Slight redness at injection site-per RN at hospital.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Lactic acidosis, Lymphadenopathy, Malaise, Myalgia
Clinical narrative: Shortness of breath, severe N/V/D, Sore throat, WBC 16.5. Slight redness at injection site-per RN at hospital.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Nausea, Neutrophil percentage increased, Oropharyngeal pain, Pain, Paraesthesia
Clinical narrative: Shortness of breath, severe N/V/D, Sore throat, WBC 16.5. Slight redness at injection site-per RN at hospital.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Pyrexia, Respiratory distress, Retching, Sepsis, Syncope
Clinical narrative: Shortness of breath, severe N/V/D, Sore throat, WBC 16.5. Slight redness at injection site-per RN at hospital.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Upper-airway cough syndrome, Vomiting, White blood cell count increased
Clinical narrative: Shortness of breath, severe N/V/D, Sore throat, WBC 16.5. Slight redness at injection site-per RN at hospital.
Age: 66.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Fatigue, Influenza like illness, Injection site reaction, Rash erythematous, Skin warm
Clinical narrative: Client had pain at vaccine sites - right and left arms. Tdap & Varicella given in left arm. Client also reported flu like symptoms and was very tired after vaccinations were given on the same day (8/19/2014). Pain in right arm resolved in 4 days. Pain in left arm has worsened since. 08/25/2014 Client noticed red patches on left arm near injection site. Client reports warmth on left arm.
Age: 66.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Vaccination site pain
Clinical narrative: Client had pain at vaccine sites - right and left arms. Tdap & Varicella given in left arm. Client also reported flu like symptoms and was very tired after vaccinations were given on the same day (8/19/2014). Pain in right arm resolved in 4 days. Pain in left arm has worsened since. 08/25/2014 Client noticed red patches on left arm near injection site. Client reports warmth on left arm.
Age: 15.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: REDNESS AND SWELLING OF INJECTED AREA, ALSO WITH PRURITUS.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site became tender, swollen, and warm to touch.
Age: 1.5
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Parent discovered patient with spotty red rash on abdomen, back, face, and upper and lower extremities. Patient was brought to the clinic with rash symptoms but unsure if it is related to vaccination received on 08/15/2014. Patient received Hepatitis A, MMR, an varicella. Patient will return to office in 2 business days for re-evaluation of symptoms.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Fever and then rashes that started on the head/face /hairline and spreading downwards.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Headache, Injection site pain, Injection site swelling, Pain
Clinical narrative: 8/25/14 Evening: soreness, swelling around injection site, body aches, headache. 8/26/14 Morning:  Headache, stomach upset, vomiting, body aches.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: 8/25/14 Evening: soreness, swelling around injection site, body aches, headache. 8/26/14 Morning:  Headache, stomach upset, vomiting, body aches.
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative, Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 22 year old females patients. On an unknown date the patient was vaccinated with M-M-R II (dose, lot # and route of administration was not reported). It was reported that patient had titers for M-M-R  drawn on unknown date and the titers came back to negative. The reporter stated that the patient was revaccinated with M-M-R II on unknown date because of this. The outcome of titers came back negative was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 22-AUG-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # J006921, expiration date 09-AUG-2014 (strength and route not reported). No adverse symptoms reported. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Dysphagia, Hypoaesthesia
Clinical narrative: Vaccine given at 4:30pm. Patient first states that her arm is numb; then she starts saying she is having trouble swallowing. Patient did not look like she was having difficulty breathing and no visible swelling. Gauze 25mg BENADRYL. Still no relief. Decided to call 911 at 5:00 pm. Patient returned to pharmacy at 7:30 w/2 scripts for prednisone and BENADRYL.
Age: 44.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Rash pustular
Clinical narrative: "Half-dollar" size induration that produced "pus" and required topical steorid cream for treatment.
Age: 62.0
Sex: F
Vaccine: FLUC3
Symptoms: Local swelling, Throat tightness
Clinical narrative: Patient reports swelling in left calf and throat closing up an hour after receiving flu vaccine patient took BENADRYL and that helped. Did not emergency treatment.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying
Clinical narrative: Unconsolable crying - x4-5 hours. No redness seen at injection sites but seemed to cry more with kicking or moving legs. OK with TYLENOL when mom finally gave at 5 hr.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pt reported chills very sore arm about 5 hours after she received the vaccine. Her right arm was unusually sore and she could hardly move the arm. Upon follow up 24 hours later (8/26/14 at around 4:30 pm) pt reported she felt better. No chills. Arm was improved bit a little sore.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Hypersomnia, Pyrexia
Clinical narrative: Patient reports extreme fatigue and has been sleeping all the time since receiving vaccine 2 days ago. Feels weak and slightly feverish. Not sure but believes its related to vaccine.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Decreased appetite, Fatigue, Malaise, Pyrexia, Rash macular
Clinical narrative: Fever, malaise, tired, no appetite, several blotch red spots, not itchy, largest red area is approximately equal to 5 inches in diameter; no itch, no SOB. Pt went to Dr 8-25 and Dr gave Rx for MEDROL dose pk and KEFLEX.
Age: 1.02
Sex: F
Vaccine: HEP, MMRV, PNC13
Symptoms: Cough, Feeling hot, Poor quality sleep, Rash, Rhinorrhoea
Clinical narrative: Mild rash varicella case. Epsom salts bath. Calamine lotion. Pt should avoid kids less than 1 yr old, pregnant females. Per pt dad pt. started to develop a rash all over her body since yesterday. Pt. got vaccines on 7/31/14 and parent is wondering if it's a reaction to the vaccines. Pt has also been coughing x1 day. Pt woke up last night 4 times and normally she sleeps through the night did notice she felt a little warm last night. Pt also has a runny nose. Patient recently did receive varicella vaccine. Rash started on trunk. Patient is eating well.
Age: 1.02
Sex: F
Vaccine: HEP, MMRV, PNC13
Symptoms: Varicella post vaccine
Clinical narrative: Mild rash varicella case. Epsom salts bath. Calamine lotion. Pt should avoid kids less than 1 yr old, pregnant females. Per pt dad pt. started to develop a rash all over her body since yesterday. Pt. got vaccines on 7/31/14 and parent is wondering if it's a reaction to the vaccines. Pt has also been coughing x1 day. Pt woke up last night 4 times and normally she sleeps through the night did notice she felt a little warm last night. Pt also has a runny nose. Patient recently did receive varicella vaccine. Rash started on trunk. Patient is eating well.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Cellulitis, Hypersensitivity, Injection site erythema, Injection site swelling, Musculoskeletal pain
Clinical narrative: Mother of child noticed (L) arm swelling, redness, and child complaining of (L) shoulder pain. Patient was taken to hospital for evaluation. Clindamycin was prescribed for 9 days. Patient had follow up 8/14/14, patient better.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a registered nurse (RN) referring to an unspecified number of patients of unknown age whose on an unknown date, were vaccinated with a doses of GARDASIL (lot, dose # and location of injection was not reported) and with a doses of other unspecified vaccines. The RN stated that recently they had numerous children (unspecified) who had fainting episodes after receiving GARDASIL and other unspecified vaccines. The outcome of fainting episodes was unknown. This is one of several reports from the same reporter source. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HIBV, PNC13, RV5
Symptoms: No adverse event
Clinical narrative: Patient was given PENTACEL and ACTHIB on the same day. No immediate adverse reaction.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to an 85 year old female patient who had shingles for a while. On an unknown date recently, the patient was vaccinated with ZOSTAVAX (lot#, expiration date, strength were unknown) dose/frequency was reported as "1 single shote", which made the shingles worse. The outcome of the event was reported as not recovered/not resolved. The reporter considered the event to be related to ZOSTAVAX. Additional information is not expected as reporter's demographics was unknown.
Sex: U
Vaccine: HEPA
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 gender. The reporter stated that since May 2014 (exact date unspecified) an unspecified number of patients received doses of vaccinated with VAQTA (dosage details, route, lot# and expiration date were not reported) that were exposed to temperatures outside of the proper storage range. No adverse effects reported. This is the one of several reports received from the same reporter. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, Product expiration date issue
Clinical narrative: This spontaneous report as received from a pharmacist via RMPDC refers to a 77 year old male patient. On 22-AUG-2014, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # J006921, expiration date 09-AUG-2014), 0.5 ml, once injection. The patient's relevant medical history, relevant concomitant medications and past drug history were unknown. The patient received the expired dose of PNEUMOVAX 23 as the pharmacist could not read the expiration date very well. The patient did not receive a second dose of PNEUMOVAX 23. The patient's relevant tests or laboratory data was unknown. The status of expired product administration was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 13-AUG-2014 (also reported as "this morning") the patient was inadvertent vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous that underwent a temperature excursion on 12-AUG-2014. The temperature excursion was supported. No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: MNQ, VARCEL, MNQ, VARCEL
Symptoms: Abasia, Convulsion, Walking aid user
Clinical narrative: Shaking, sweating, pain in back of head and legs, legs uncontrollable spasm, couldn't walk.
Age: 16.0
Sex: F
Vaccine: MNQ, VARCEL, MNQ, VARCEL
Symptoms: Abasia, Headache, Hyperhidrosis, Muscle spasms, Pain in extremity
Clinical narrative: Shaking, sweating, pain in back of head and legs, legs uncontrollable spasm, couldn't walk.
Age: 16.0
Sex: F
Vaccine: MNQ, VARCEL, MNQ, VARCEL
Symptoms: Tremor, Walking aid user
Clinical narrative: Shaking, sweating, pain in back of head and legs, legs uncontrollable spasm, couldn't walk.
Age: 13.0
Sex: M
Vaccine: HIBV, MEN, PPV, PPV
Symptoms: Chills, Computerised tomogram, Dizziness, Headache, Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 13 year old male patient without any pertinent medical history, drug reactions or allergies. On 08-AUG-2014 the patient was vaccinated with PNEUMOVAX 23 lot # J009723, expiration date 30-JAN-2015, intramuscular (dose and strength were not reported). Concomitant therapies included COLACE. On 09-AUG-2014, the patient developed cellulitis on an unspecified area of the body and he was admitted to urgent care (UC). On that same day, patient started clindamycin. The patient was discharge from UC on 12-AUG-2014. The patient's present status was not specified. Labs diagnostics studies performed were a full blood count and a chemistry panel (result were not provided). Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HIBV, MEN, PPV, PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 13 year old male patient without any pertinent medical history, drug reactions or allergies. On 08-AUG-2014 the patient was vaccinated with PNEUMOVAX 23 lot # J009723, expiration date 30-JAN-2015, intramuscular (dose and strength were not reported). Concomitant therapies included COLACE. On 09-AUG-2014, the patient developed cellulitis on an unspecified area of the body and he was admitted to urgent care (UC). On that same day, patient started clindamycin. The patient was discharge from UC on 12-AUG-2014. The patient's present status was not specified. Labs diagnostics studies performed were a full blood count and a chemistry panel (result were not provided). Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HIBV, MEN, PPV, PPV
Symptoms: Cellulitis, Full blood count, Laboratory test
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 13 year old male patient without any pertinent medical history, drug reactions or allergies. On 08-AUG-2014 the patient was vaccinated with PNEUMOVAX 23 lot # J009723, expiration date 30-JAN-2015, intramuscular (dose and strength were not reported). Concomitant therapies included COLACE. On 09-AUG-2014, the patient developed cellulitis on an unspecified area of the body and he was admitted to urgent care (UC). On that same day, patient started clindamycin. The patient was discharge from UC on 12-AUG-2014. The patient's present status was not specified. Labs diagnostics studies performed were a full blood count and a chemistry panel (result were not provided). Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PPV, RVX
Symptoms: Blood immunoglobulin A abnormal, Blood immunoglobulin G normal, Complement factor C3, Complement factor normal, Coombs direct test positive
Clinical narrative: This literature marketed report as received from a health professional refers to a 4 month old male patient. On an unknown date the patient was vaccinated with Hib vaccine (manufacturer unknown) (dose, route and lot# not reported). Other concomitant therapies included pneumococcal vaccine (manufacturer unknown) (dose, route and lot# not reported), rotavirus vaccine (manufacturer unknown) (dose, route and lot# not reported), DTAP and IPOL on an unspecified date. It was reported that the patient developed hemolytic anemia shortly after receiving his four month immunizations including Hib vaccine (manufacturer unknown), pneumococcal vaccine (manufacturer unknown), rotavirus vaccine (manufacturer unknown), DTAP and IPOL. The authors described the method of isolating the causative vaccine, Hib vaccine (manufacturer unknown), during his 6 month immunizations. Design/Method: Case Report. Results: Following two days of irritability, vomiting, and dark stools, the patient was found to have an initial hemoglobin of 2.7 g/dL at a community hospital. He was transferred to the academic center where he had a weakly positive direct antiglobulin test with negative complement component 3 and immunoglobulin G. Further testing revealed immunoglobulin A mediated autoantibodies. Significant improvement in his hemoglobin was observed after oral corticosteroid administration. A staggered approach was utilized for administering his 6 month immunizations which included serial complete blood counts following each individual vaccine to monitor for evidence of hemolysis. IPOL and DTAP vaccines were given without incident. However after administration of the Hib vaccine, his hemoglobin dropped to 7.0 g/dL, with hemolysis, suggesting that this vaccine was responsible for the initial episode. The authors planned to give him further Hib vaccine (manufacturer unknown) vaccine doses with steroid pretreatment. The outcome of autoimmune hemolytic anemia was reported as recovering/resolving. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PPV, RVX
Symptoms: Faeces discoloured, Haemoglobin decreased, Haemolysis, Haemolytic anaemia, Irritability
Clinical narrative: This literature marketed report as received from a health professional refers to a 4 month old male patient. On an unknown date the patient was vaccinated with Hib vaccine (manufacturer unknown) (dose, route and lot# not reported). Other concomitant therapies included pneumococcal vaccine (manufacturer unknown) (dose, route and lot# not reported), rotavirus vaccine (manufacturer unknown) (dose, route and lot# not reported), DTAP and IPOL on an unspecified date. It was reported that the patient developed hemolytic anemia shortly after receiving his four month immunizations including Hib vaccine (manufacturer unknown), pneumococcal vaccine (manufacturer unknown), rotavirus vaccine (manufacturer unknown), DTAP and IPOL. The authors described the method of isolating the causative vaccine, Hib vaccine (manufacturer unknown), during his 6 month immunizations. Design/Method: Case Report. Results: Following two days of irritability, vomiting, and dark stools, the patient was found to have an initial hemoglobin of 2.7 g/dL at a community hospital. He was transferred to the academic center where he had a weakly positive direct antiglobulin test with negative complement component 3 and immunoglobulin G. Further testing revealed immunoglobulin A mediated autoantibodies. Significant improvement in his hemoglobin was observed after oral corticosteroid administration. A staggered approach was utilized for administering his 6 month immunizations which included serial complete blood counts following each individual vaccine to monitor for evidence of hemolysis. IPOL and DTAP vaccines were given without incident. However after administration of the Hib vaccine, his hemoglobin dropped to 7.0 g/dL, with hemolysis, suggesting that this vaccine was responsible for the initial episode. The authors planned to give him further Hib vaccine (manufacturer unknown) vaccine doses with steroid pretreatment. The outcome of autoimmune hemolytic anemia was reported as recovering/resolving. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PPV, RVX
Symptoms: Vomiting
Clinical narrative: This literature marketed report as received from a health professional refers to a 4 month old male patient. On an unknown date the patient was vaccinated with Hib vaccine (manufacturer unknown) (dose, route and lot# not reported). Other concomitant therapies included pneumococcal vaccine (manufacturer unknown) (dose, route and lot# not reported), rotavirus vaccine (manufacturer unknown) (dose, route and lot# not reported), DTAP and IPOL on an unspecified date. It was reported that the patient developed hemolytic anemia shortly after receiving his four month immunizations including Hib vaccine (manufacturer unknown), pneumococcal vaccine (manufacturer unknown), rotavirus vaccine (manufacturer unknown), DTAP and IPOL. The authors described the method of isolating the causative vaccine, Hib vaccine (manufacturer unknown), during his 6 month immunizations. Design/Method: Case Report. Results: Following two days of irritability, vomiting, and dark stools, the patient was found to have an initial hemoglobin of 2.7 g/dL at a community hospital. He was transferred to the academic center where he had a weakly positive direct antiglobulin test with negative complement component 3 and immunoglobulin G. Further testing revealed immunoglobulin A mediated autoantibodies. Significant improvement in his hemoglobin was observed after oral corticosteroid administration. A staggered approach was utilized for administering his 6 month immunizations which included serial complete blood counts following each individual vaccine to monitor for evidence of hemolysis. IPOL and DTAP vaccines were given without incident. However after administration of the Hib vaccine, his hemoglobin dropped to 7.0 g/dL, with hemolysis, suggesting that this vaccine was responsible for the initial episode. The authors planned to give him further Hib vaccine (manufacturer unknown) vaccine doses with steroid pretreatment. The outcome of autoimmune hemolytic anemia was reported as recovering/resolving. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Computerised tomogram, Full blood count, Grand mal convulsion, Metabolic function test
Clinical narrative: Patient had a 30 second tonic clonic seizure 2 days after vaccine. No previous history or seizures.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Asthenia, Asthma, Back pain, Chest pain, Cough
Clinical narrative: Information has been received from a registered nurse regarding a currently 14 year old male patient with attention deficit hyperactivity disorder and an unspecified drug reactions or allergies. On an unknown date, the patient was vaccinated with his first dose of GARDASIL (dose, lot number and expiration date were not provided) along with an unspecified Hepatitis A vaccine (manufacturer unknown) (dose, lot number and expiration date were not provided). Concomitant therapies included an unspecified meningococcal vaccine (dose and lot number were not provided) and unspecified medication for attention deficit hyperactivity disorder. On an unknown date, the patient experienced syncope within minutes of being administered the GARDASIL. The patient initially became light headed, and then experienced syncope. The patient still felt weak after recovering from the fainting spell. An ambulance was called and the patient was taken to the hospital. The patient was observed in the Emergency room and was given an electrocardiogram (EKG) with no abnormal findings. The patient was then sent home. The Patient was taken to the hospital Emergency room again later in the same day complaining of back pain, chest pain and coughing and shortness of breath on an unspecified date. He was admitted to hospital where he received fluids and was observed. He was transferred to another hospital, on an unspecified date and discharged on an unspecified date with a diagnosis of a "viral infection". Patient is still complaining of cough and asthma-like symptoms. The patient sought medical attention, was to emergency room. At the time of the report, the patient had not recovered from the adverse event (viral infection). Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Dizziness, Dyspnoea, Electrocardiogram normal, Syncope, Viral infection
Clinical narrative: Information has been received from a registered nurse regarding a currently 14 year old male patient with attention deficit hyperactivity disorder and an unspecified drug reactions or allergies. On an unknown date, the patient was vaccinated with his first dose of GARDASIL (dose, lot number and expiration date were not provided) along with an unspecified Hepatitis A vaccine (manufacturer unknown) (dose, lot number and expiration date were not provided). Concomitant therapies included an unspecified meningococcal vaccine (dose and lot number were not provided) and unspecified medication for attention deficit hyperactivity disorder. On an unknown date, the patient experienced syncope within minutes of being administered the GARDASIL. The patient initially became light headed, and then experienced syncope. The patient still felt weak after recovering from the fainting spell. An ambulance was called and the patient was taken to the hospital. The patient was observed in the Emergency room and was given an electrocardiogram (EKG) with no abnormal findings. The patient was then sent home. The Patient was taken to the hospital Emergency room again later in the same day complaining of back pain, chest pain and coughing and shortness of breath on an unspecified date. He was admitted to hospital where he received fluids and was observed. He was transferred to another hospital, on an unspecified date and discharged on an unspecified date with a diagnosis of a "viral infection". Patient is still complaining of cough and asthma-like symptoms. The patient sought medical attention, was to emergency room. At the time of the report, the patient had not recovered from the adverse event (viral infection). Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Back pain, Chest X-ray, Chest pain, Cough, Laboratory test
Clinical narrative: Information has been received from a registered nurse regarding a currently 14 year old male patient with attention deficit hyperactivity disorder and an unspecified drug reactions or allergies. On an unknown date, the patient was vaccinated with his first dose of GARDASIL (dose, lot number and expiration date were not provided) along with an unspecified Hepatitis A vaccine (manufacturer unknown) (dose, lot number and expiration date were not provided). Concomitant therapies included an unspecified meningococcal vaccine (dose and lot number were not provided) and unspecified medication for attention deficit hyperactivity disorder. On an unknown date, the patient experienced syncope within minutes of being administered the GARDASIL. The patient initially became light headed, and then experienced syncope. The patient still felt weak after recovering from the fainting spell. An ambulance was called and the patient was taken to the hospital. The patient was observed in the Emergency room and was given an electrocardiogram (EKG) with no abnormal findings. The patient was then sent home. The Patient was taken to the hospital Emergency room again later in the same day complaining of back pain, chest pain and coughing and shortness of breath on an unspecified date. He was admitted to hospital where he received fluids and was observed. He was transferred to another hospital, on an unspecified date and discharged on an unspecified date with a diagnosis of a "viral infection". Patient is still complaining of cough and asthma-like symptoms. The patient sought medical attention, was to emergency room. At the time of the report, the patient had not recovered from the adverse event (viral infection). Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse regarding a currently 14 year old male patient with attention deficit hyperactivity disorder and an unspecified drug reactions or allergies. On an unknown date, the patient was vaccinated with his first dose of GARDASIL (dose, lot number and expiration date were not provided) along with an unspecified Hepatitis A vaccine (manufacturer unknown) (dose, lot number and expiration date were not provided). Concomitant therapies included an unspecified meningococcal vaccine (dose and lot number were not provided) and unspecified medication for attention deficit hyperactivity disorder. On an unknown date, the patient experienced syncope within minutes of being administered the GARDASIL. The patient initially became light headed, and then experienced syncope. The patient still felt weak after recovering from the fainting spell. An ambulance was called and the patient was taken to the hospital. The patient was observed in the Emergency room and was given an electrocardiogram (EKG) with no abnormal findings. The patient was then sent home. The Patient was taken to the hospital Emergency room again later in the same day complaining of back pain, chest pain and coughing and shortness of breath on an unspecified date. He was admitted to hospital where he received fluids and was observed. He was transferred to another hospital, on an unspecified date and discharged on an unspecified date with a diagnosis of a "viral infection". Patient is still complaining of cough and asthma-like symptoms. The patient sought medical attention, was to emergency room. At the time of the report, the patient had not recovered from the adverse event (viral infection). Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Foster mom noticed swollen, warm to touch leg while giving her a bath last night.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Inflammation, Rash
Clinical narrative: Small rash and inflammation on left arm. No fever.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Headache, Metrorrhagia, Nausea
Clinical narrative: Daily nausea and vomiting, headaches, fatigue, body aches, rash, break thru menstral bleeding, dizzy.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Rash, Vomiting
Clinical narrative: Daily nausea and vomiting, headaches, fatigue, body aches, rash, break thru menstral bleeding, dizzy.
Age: 60.0
Sex: M
Vaccine: MNQ
Symptoms: Wrong drug administered
Clinical narrative: Patient and his wife received Meningococal Conjugate instead of Meningococcal Polysaccaride. Patient was 60 and wife 59 at the time of administration.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Alopecia, Amnesia, Back pain, Chest pain
Clinical narrative: Daily headaches, nausea and vomiting, pale gray dry skin, bumps, lesions, eye infections, hair loss, insomnia, fatigue, fainting, muscle weakness, clumsy, brain fog, memory loss, night sweats, frequent infections, UTIs and yeast, sore throat, chest pain, sinus, limb numbness, tremors, irregular periods with excessive cramping and vomiting, constipation stomach and back pain, light sensitive, nosebleeds.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Clumsiness, Constipation, Dysmenorrhoea, Epistaxis, Eye infection
Clinical narrative: Daily headaches, nausea and vomiting, pale gray dry skin, bumps, lesions, eye infections, hair loss, insomnia, fatigue, fainting, muscle weakness, clumsy, brain fog, memory loss, night sweats, frequent infections, UTIs and yeast, sore throat, chest pain, sinus, limb numbness, tremors, irregular periods with excessive cramping and vomiting, constipation stomach and back pain, light sensitive, nosebleeds.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Feeling abnormal, Headache, Hypoaesthesia, Infection
Clinical narrative: Daily headaches, nausea and vomiting, pale gray dry skin, bumps, lesions, eye infections, hair loss, insomnia, fatigue, fainting, muscle weakness, clumsy, brain fog, memory loss, night sweats, frequent infections, UTIs and yeast, sore throat, chest pain, sinus, limb numbness, tremors, irregular periods with excessive cramping and vomiting, constipation stomach and back pain, light sensitive, nosebleeds.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Insomnia, Menstruation irregular, Muscular weakness, Nausea, Night sweats
Clinical narrative: Daily headaches, nausea and vomiting, pale gray dry skin, bumps, lesions, eye infections, hair loss, insomnia, fatigue, fainting, muscle weakness, clumsy, brain fog, memory loss, night sweats, frequent infections, UTIs and yeast, sore throat, chest pain, sinus, limb numbness, tremors, irregular periods with excessive cramping and vomiting, constipation stomach and back pain, light sensitive, nosebleeds.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Oropharyngeal pain, Pallor, Photophobia, Rash, Sinus disorder
Clinical narrative: Daily headaches, nausea and vomiting, pale gray dry skin, bumps, lesions, eye infections, hair loss, insomnia, fatigue, fainting, muscle weakness, clumsy, brain fog, memory loss, night sweats, frequent infections, UTIs and yeast, sore throat, chest pain, sinus, limb numbness, tremors, irregular periods with excessive cramping and vomiting, constipation stomach and back pain, light sensitive, nosebleeds.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Skin lesion, Syncope, Tremor, Urinary tract infection, Urinary tract infection fungal
Clinical narrative: Daily headaches, nausea and vomiting, pale gray dry skin, bumps, lesions, eye infections, hair loss, insomnia, fatigue, fainting, muscle weakness, clumsy, brain fog, memory loss, night sweats, frequent infections, UTIs and yeast, sore throat, chest pain, sinus, limb numbness, tremors, irregular periods with excessive cramping and vomiting, constipation stomach and back pain, light sensitive, nosebleeds.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Daily headaches, nausea and vomiting, pale gray dry skin, bumps, lesions, eye infections, hair loss, insomnia, fatigue, fainting, muscle weakness, clumsy, brain fog, memory loss, night sweats, frequent infections, UTIs and yeast, sore throat, chest pain, sinus, limb numbness, tremors, irregular periods with excessive cramping and vomiting, constipation stomach and back pain, light sensitive, nosebleeds.
Age: 41.0
Sex: M
Vaccine: MMR
Symptoms: Ear swelling, Eyelid oedema, Generalised erythema, Local swelling, Swelling face
Clinical narrative: Pt complained of redness and swelling on inner right arm (not on injection site), both ears, nose, upper eyelids and under eyes x 8 days. Pt did not seek treatment after reaction.
Age: 1.09
Sex: M
Vaccine: MMR, PNC13
Symptoms: Autoimmune thrombocytopenia, Blister, Ecchymosis, Petechiae
Clinical narrative: Ecchymosis on left forehead and bilateral knees/shins, petechiae on right upper leg, diffusely on chest and back and extremities, no purpura.  Patient referred to Dr. for an appointment at heme clinic.
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal discomfort, Influenza, Joint stiffness, Musculoskeletal stiffness, Pain
Clinical narrative: Body ache from head to toe; flu GI distress; continued joint, muscle tendon stiffness.
Age: 58.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Two raised, reddened areas on left inner wrist and right upper forearm that expanded over time.  Also itched.
Age: 58.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Urticaria
Clinical narrative: Two raised, reddened areas on left inner wrist and right upper forearm that expanded over time.  Also itched.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: REDNESS TO RIGHT DELTOID, SMALL HIVE DEVELOPED WARM TO TOUCH. WALKED INTO CLINIC ON 08/20/14 FOR DR TO REVIEW, PATIENT STATES IT WAS LARGER FROM THE FIRST DAY. HIVES WAS FROM SHOULDER TO ELBOW IN SIZE.