chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: This is a spontaneous report from a contactable medical assistant on behalf of a physician. A 82 years old female patient received PREVNAR 13 (lot. J80527, exp. date 01May2015) on 23Mar2015 at 10:30, 0.5ml single dose intramuscular on upper left arm. 24 hours later, the next day, the patient experienced fever 101 Fahrenheit and elevated white blood cell count at 19,000 and she was hospitalized for the events. The patient was administered antibiotics of unknown name while in the hospital. The outcome of the event fever was reported as recovering while for the event elevated white blood cell count was reported as not recovered.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Influenza like illness, Paraesthesia, Rash
Clinical narrative: Herpes zoster diagnosis in Zostavax recipient. Burning tingling rash on right side of neck. Flu-like symptoms x 3 days. No pain, no blistering. Hx of varicella at age 6. Hx of herpes zoster in fall 2012. Treated with Valtrex.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Dyspnoea, Hypersensitivity, Lip swelling, Rash, Swelling face
Clinical narrative: Phone call from parent after patient left office reporting patient was having acute allergic reaction with rash, facial swelling, lip swelling, tongue swelling, difficulty breathing, and wheezing. Parent reported facial rash started at doctor's office but she did not report it to anyone. Parent was advised to administer EpiPen patient had on hand for known food allergies and call 911 for emergancy medical attention. Parent gave EpiPen, Xopenex inhaler and oral Benadryl but did not seek emergancy medical attenntion as instructed.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Swollen tongue, Wheezing
Clinical narrative: Phone call from parent after patient left office reporting patient was having acute allergic reaction with rash, facial swelling, lip swelling, tongue swelling, difficulty breathing, and wheezing. Parent reported facial rash started at doctor's office but she did not report it to anyone. Parent was advised to administer EpiPen patient had on hand for known food allergies and call 911 for emergancy medical attention. Parent gave EpiPen, Xopenex inhaler and oral Benadryl but did not seek emergancy medical attenntion as instructed.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site reaction, Rash macular
Clinical narrative: Mother states that 1 week after receiving his Kinrix vaccine, he developed a large (baseball size) read area with "blotching" around the injection site. No fever or other sx.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pain, Pyrexia
Clinical narrative: Fever 99F up to 100.4F for 4 hours, generalized achiness especially left arm at site of injection, redness and warmth of localized area above elbow.
Age: 24.0
Sex: M
Vaccine: FLU3, HEPA, TYP, YF, FLU3, HEPA, TYP, YF
Symptoms: Fatigue, Headache, Lymphadenopathy, Mononucleosis heterophile test negative, Myalgia
Clinical narrative: On 03/25/15 client called the health department to report having swollen lymph nodes, sore muscles, fatigue. Denied having a fever, airway compromise, or hives/rash. Stated he had a runny nose on Monday. Client went backcountry skiing all day 03/24/15. Client asked PHN about going to a concert tonight and drinking. Client encouraged to rest, take Motrin and rehydrate. Instructed client to call Dr if symptoms worsen. On 03/26/15 client went to urgent care. Per medical records he had negative mono and strep tests and 3+ tonsils with white exudates. Urgent care diagnosis: tonsillitis and possible vaccine reaction. Client was given prednisone taper and ibuprofen. On 03/29/15 client to ER. Per records from this visit, client had a fever of 38.1, airway patent and open, breathing spontaneous and non labored, no evidence or symptoms to suggest allergic reaction. Diagnosis from ER: Tonsillitis. Client given Augumentin. On 04/03/15 client's mom called health department to report continued symptoms and ER/urgent care visits, stating that she had read that tonsillitis was a rare adverse event from typhoid vaccine. Per client's mom, steroids and antibiotics "have not helped." Mom states that client can swallow better, but tonsils and throat "visible looks the same." Client's mom denied client having trouble breathing. Mom also stated that client had had a severe headache after vaccinations and still had occasional headaches. Client took Tylenol for severe headache and mom reported that it helped. Mom also reported that client's tongue was swollen. Client was called this same day by PHN to check in. Client was encouraged to finish antibiotics to fight off tonsil infection. Client denied having trouble breathing and stated his throat and tonsils felt the same. Client encouraged to call primary care physician/urgent care or seek medical help if infection worsens or if it does not improve after finishing antibiotics.
Age: 24.0
Sex: M
Vaccine: FLU3, HEPA, TYP, YF, FLU3, HEPA, TYP, YF
Symptoms: Pyrexia, Rhinorrhoea, Streptococcus test negative, Swollen tongue, Tonsillitis
Clinical narrative: On 03/25/15 client called the health department to report having swollen lymph nodes, sore muscles, fatigue. Denied having a fever, airway compromise, or hives/rash. Stated he had a runny nose on Monday. Client went backcountry skiing all day 03/24/15. Client asked PHN about going to a concert tonight and drinking. Client encouraged to rest, take Motrin and rehydrate. Instructed client to call Dr if symptoms worsen. On 03/26/15 client went to urgent care. Per medical records he had negative mono and strep tests and 3+ tonsils with white exudates. Urgent care diagnosis: tonsillitis and possible vaccine reaction. Client was given prednisone taper and ibuprofen. On 03/29/15 client to ER. Per records from this visit, client had a fever of 38.1, airway patent and open, breathing spontaneous and non labored, no evidence or symptoms to suggest allergic reaction. Diagnosis from ER: Tonsillitis. Client given Augumentin. On 04/03/15 client's mom called health department to report continued symptoms and ER/urgent care visits, stating that she had read that tonsillitis was a rare adverse event from typhoid vaccine. Per client's mom, steroids and antibiotics "have not helped." Mom states that client can swallow better, but tonsils and throat "visible looks the same." Client's mom denied client having trouble breathing. Mom also stated that client had had a severe headache after vaccinations and still had occasional headaches. Client took Tylenol for severe headache and mom reported that it helped. Mom also reported that client's tongue was swollen. Client was called this same day by PHN to check in. Client was encouraged to finish antibiotics to fight off tonsil infection. Client denied having trouble breathing and stated his throat and tonsils felt the same. Client encouraged to call primary care physician/urgent care or seek medical help if infection worsens or if it does not improve after finishing antibiotics.
Age: 24.0
Sex: M
Vaccine: FLU3, HEPA, TYP, YF, FLU3, HEPA, TYP, YF
Symptoms: Dysphagia, Fatigue, Headache, Lymphadenopathy, Mononucleosis heterophile test negative
Clinical narrative: On 03/25/15 client called the health department to report having swollen lymph nodes, sore muscles, fatigue. Denied having a fever, airway compromise, or hives/rash. Stated he had a runny nose on Monday. Client went backcountry skiing all day 03/24/15. Client asked PHN about going to a concert tonight and drinking. Client encouraged to rest, take Motrin and rehydrate. Instructed client to call Dr if symptoms worsen. On 03/26/15 client went to urgent care. Per medical records he had negative mono and strep tests and 3+ tonsils with white exudates. Urgent care diagnosis: tonsillitis and possible vaccine reaction. Client was given prednisone taper and ibuprofen. On 03/29/15 client to ER. Per records from this visit, client had a fever of 38.1, airway patent and open, breathing spontaneous and non labored, no evidence or symptoms to suggest allergic reaction. Diagnosis from ER: Tonsillitis. Client given Augumentin. On 04/03/15 client's mom called health department to report continued symptoms and ER/urgent care visits, stating that she had read that tonsillitis was a rare adverse event from typhoid vaccine. Per client's mom, steroids and antibiotics "have not helped." Mom states that client can swallow better, but tonsils and throat "visible looks the same." Client's mom denied client having trouble breathing. Mom also stated that client had had a severe headache after vaccinations and still had occasional headaches. Client took Tylenol for severe headache and mom reported that it helped. Mom also reported that client's tongue was swollen. Client was called this same day by PHN to check in. Client was encouraged to finish antibiotics to fight off tonsil infection. Client denied having trouble breathing and stated his throat and tonsils felt the same. Client encouraged to call primary care physician/urgent care or seek medical help if infection worsens or if it does not improve after finishing antibiotics.
Age: 24.0
Sex: M
Vaccine: FLU3, HEPA, TYP, YF, FLU3, HEPA, TYP, YF
Symptoms: Myalgia, Pyrexia, Rhinorrhoea, Streptococcus test negative, Swollen tongue
Clinical narrative: On 03/25/15 client called the health department to report having swollen lymph nodes, sore muscles, fatigue. Denied having a fever, airway compromise, or hives/rash. Stated he had a runny nose on Monday. Client went backcountry skiing all day 03/24/15. Client asked PHN about going to a concert tonight and drinking. Client encouraged to rest, take Motrin and rehydrate. Instructed client to call Dr if symptoms worsen. On 03/26/15 client went to urgent care. Per medical records he had negative mono and strep tests and 3+ tonsils with white exudates. Urgent care diagnosis: tonsillitis and possible vaccine reaction. Client was given prednisone taper and ibuprofen. On 03/29/15 client to ER. Per records from this visit, client had a fever of 38.1, airway patent and open, breathing spontaneous and non labored, no evidence or symptoms to suggest allergic reaction. Diagnosis from ER: Tonsillitis. Client given Augumentin. On 04/03/15 client's mom called health department to report continued symptoms and ER/urgent care visits, stating that she had read that tonsillitis was a rare adverse event from typhoid vaccine. Per client's mom, steroids and antibiotics "have not helped." Mom states that client can swallow better, but tonsils and throat "visible looks the same." Client's mom denied client having trouble breathing. Mom also stated that client had had a severe headache after vaccinations and still had occasional headaches. Client took Tylenol for severe headache and mom reported that it helped. Mom also reported that client's tongue was swollen. Client was called this same day by PHN to check in. Client was encouraged to finish antibiotics to fight off tonsil infection. Client denied having trouble breathing and stated his throat and tonsils felt the same. Client encouraged to call primary care physician/urgent care or seek medical help if infection worsens or if it does not improve after finishing antibiotics.
Age: 24.0
Sex: M
Vaccine: FLU3, HEPA, TYP, YF, FLU3, HEPA, TYP, YF
Symptoms: Tonsillitis
Clinical narrative: On 03/25/15 client called the health department to report having swollen lymph nodes, sore muscles, fatigue. Denied having a fever, airway compromise, or hives/rash. Stated he had a runny nose on Monday. Client went backcountry skiing all day 03/24/15. Client asked PHN about going to a concert tonight and drinking. Client encouraged to rest, take Motrin and rehydrate. Instructed client to call Dr if symptoms worsen. On 03/26/15 client went to urgent care. Per medical records he had negative mono and strep tests and 3+ tonsils with white exudates. Urgent care diagnosis: tonsillitis and possible vaccine reaction. Client was given prednisone taper and ibuprofen. On 03/29/15 client to ER. Per records from this visit, client had a fever of 38.1, airway patent and open, breathing spontaneous and non labored, no evidence or symptoms to suggest allergic reaction. Diagnosis from ER: Tonsillitis. Client given Augumentin. On 04/03/15 client's mom called health department to report continued symptoms and ER/urgent care visits, stating that she had read that tonsillitis was a rare adverse event from typhoid vaccine. Per client's mom, steroids and antibiotics "have not helped." Mom states that client can swallow better, but tonsils and throat "visible looks the same." Client's mom denied client having trouble breathing. Mom also stated that client had had a severe headache after vaccinations and still had occasional headaches. Client took Tylenol for severe headache and mom reported that it helped. Mom also reported that client's tongue was swollen. Client was called this same day by PHN to check in. Client was encouraged to finish antibiotics to fight off tonsil infection. Client denied having trouble breathing and stated his throat and tonsils felt the same. Client encouraged to call primary care physician/urgent care or seek medical help if infection worsens or if it does not improve after finishing antibiotics.
Age: 62.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Musculoskeletal pain, Pain
Clinical narrative: Constant left arm (injection arm) shoulder collar bone shoulder blade pain that increases with motion, especially raising the left arm above the head.
Age: 62.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Bone pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Constant left arm (injection arm) shoulder collar bone shoulder blade pain that increases with motion, especially raising the left arm above the head.
Age: 14.0
Sex: F
Vaccine: DTAP, HEP, IPV, MMR, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Tdap was ordered, but Dtap was given.  No adverse reactions noted, parent of patient notified.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Chills, Diarrhoea, Erythema, Injection site mass
Clinical narrative: Swelling and redness that was 10 inches down my arm and around deltoid. Hives, chills, diarrhea, itchy, hard lump at site of vaccine, right side of face swelled. Vaccine given in right arm. Also blistering and peeling of skin. Treatment included Benadryl and Prednisone.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Peripheral swelling, Skin exfoliation, Swelling face, Urticaria
Clinical narrative: Swelling and redness that was 10 inches down my arm and around deltoid. Hives, chills, diarrhea, itchy, hard lump at site of vaccine, right side of face swelled. Vaccine given in right arm. Also blistering and peeling of skin. Treatment included Benadryl and Prednisone.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination site induration
Clinical narrative: Swelling and redness that was 10 inches down my arm and around deltoid. Hives, chills, diarrhea, itchy, hard lump at site of vaccine, right side of face swelled. Vaccine given in right arm. Also blistering and peeling of skin. Treatment included Benadryl and Prednisone.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Unevaluable event
Clinical narrative: Swelling and redness that was 10 inches down my arm and around deltoid. Hives, chills, diarrhea, itchy, hard lump at site of vaccine, right side of face swelled. Vaccine given in right arm. Also blistering and peeling of skin. Treatment included Benadryl and Prednisone.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Pallor, Tremor
Clinical narrative: Pt was resting, sitting on exam table, informed mother he was "feeling lightheaded".  Pt lost consciousness for about 5-10 seconds. Mother stated child had "shaking", concerned he had a seizure. Child alert and able to answer questions from healthcare providers after 10 seconds, placed in Trendelenburg position, monitored BP, HR, RR. Given cool cloth to face, was sl. diaphoretic and pale. Given gatorade. Gradually felt better. Sat up and observed x 20 minutes. No longer dizzy or lightheaded, he is alert and approriate. Examined by MD and sent home with parent.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Intussusception, Vomiting
Clinical narrative: Initial vomiting, diagnosis of intussusception.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse referring to an adult patient of unknown age and gender. The patient was supposed to received a dose of M-M-R II and VARIVAX (Merck) on 31-MAR-2015 for the second dose in the series. However, the patient received a dose of VARIVAX (Merck)  and a dose of PROQUAD (Merck) injection, subcutaneously. No adverse effects were reported. Additional information is not expected because the reporter did not want to be contacted.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a health professional concerning an unspecified number of unspecified patients. No concurrent or historical conditions were reported. On unspecified dates since 01-NOV-2014, the patients were vaccinated with unspecified number of improperly stored doses of GARDASIL (dose, strength, lot # and route were not reported). No adverse effects were reported. This case was one of three cases received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Erythema, Fatigue, Insomnia, Pruritus
Clinical narrative: Information has been received from a consumer referring to her father, a pacemaker user, with diabetes mellitus and unspecified heart condition. The patient had a medical history of three or four outbreaks of shingles (dates unspecified) (each shingles outbreak seemed progressively worse than the last). On an unspecified date after that, the patient received a dose of ZOSTAVAX (lot number, expiration date and dose were unknown), subcutaneously. Concomitant therapies included lisinopril (manufacturer unknown), warfarin, hydrochlorothiazide (manufacture unknown), simvastatin (manufacture unknown), glipizide and NOVOLIN. On an unknown date (timeframe unspecified), the patient seemed to develop severe itching, redness, a rash and fatigue with sleeplessness since being administered ZOSTAVAX. The patient had gone to four physician follow up visits and also to the Emergency Room and to an Urgent Care for a diagnosis and treatment for the itching. Regular blood work checkups were performed, but the result was unknown, and the patient had been misdiagnosed with having dermatitis and allergic reaction. The patient was given the following treatment for itching: hydrocortisone, hydroxyzine pamoate and ammonium cream. At the time of report, the patient was still having sporadic outbreaks that include severe itching and was up "all last night" because it would not subside. The outcome of the other events was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a consumer referring to her father, a pacemaker user, with diabetes mellitus and unspecified heart condition. The patient had a medical history of three or four outbreaks of shingles (dates unspecified) (each shingles outbreak seemed progressively worse than the last). On an unspecified date after that, the patient received a dose of ZOSTAVAX (lot number, expiration date and dose were unknown), subcutaneously. Concomitant therapies included lisinopril (manufacturer unknown), warfarin, hydrochlorothiazide (manufacture unknown), simvastatin (manufacture unknown), glipizide and NOVOLIN. On an unknown date (timeframe unspecified), the patient seemed to develop severe itching, redness, a rash and fatigue with sleeplessness since being administered ZOSTAVAX. The patient had gone to four physician follow up visits and also to the Emergency Room and to an Urgent Care for a diagnosis and treatment for the itching. Regular blood work checkups were performed, but the result was unknown, and the patient had been misdiagnosed with having dermatitis and allergic reaction. The patient was given the following treatment for itching: hydrocortisone, hydroxyzine pamoate and ammonium cream. At the time of report, the patient was still having sporadic outbreaks that include severe itching and was up "all last night" because it would not subside. The outcome of the other events was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a health professional concerning unspecified number of unspecified patients. No concurrent or historical conditions were reported. On unspecified dates since 01-NOV-2014, the patients were vaccinated with unspecified number or improperly stored doses of VAQTA (dose, strength, lot # and route were not reported). No adverse effects were reported. This case was one of three cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. No information about medical history, concurrent conditions was reported for the patient. On 02-APR-2015 the patient was vaccinated inadvertently with oral, ROTATEQ (dose strength unspecified) which expired on 31-MAR-2015. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 14 year old patient of an unknown gender. On an unknown date, the patient was vaccinated with a dose of PROQUAD (Merck) (dose, route, lot # and expiration date were not provided) which was considered an inappropriate schedule of vaccine administered. No adverse effect reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Paraesthesia, Pruritus, Swelling
Clinical narrative: Patient developed a red, raised area-size of a quarter night of injection. Gradually became the size of a lg-grapefruit and was itchy, tingle, and painful. Ibuprofen 600mg x 8hrs. F/U on Monday 4/6/15.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Induration, Peripheral swelling, Skin warm
Clinical narrative: Large swollen area on (L) deltoid, hard and warm to touch. Vaccine (TDAP) given 4/1/15. 845am.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Induration, Injection site erythema, Injection site papule, Macule
Clinical narrative: Blanchable erythematous macules on trunk, 3-5 mm indurated confluent, 1-2 cm of erythema with 2-3 raised papules on the (R) lateral thigh.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pallor
Clinical narrative: Blanchable erythematous macules on trunk, 3-5 mm indurated confluent, 1-2 cm of erythema with 2-3 raised papules on the (R) lateral thigh.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Had a rash on the upper secotion of his arm. Not itchy or hot to the touch.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified patient (age and gender unknown). Information about patient's current condition or medical history was not reported. On 01-APR-2015 the patient was administered with a dose of ZOSTAVAX (dose, route not reported, lot # K014834 with expiration date 14-DEC-2015) which was exposed to a temperature outside of the recommended range. No adverse effect was observed or reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: RUB
Symptoms: Activities of daily living impaired, Peripheral swelling
Clinical narrative: This spontaneous report as received from a register nurse, refers to a currently 39 year old female patient, with asthma and latex allergy. The patient was also not immune to measles. On an unknown date approximately in 1990, when the patient was 15 year old, was vaccinated with MERUVAX II, (strength, dosage, route and lot# were not reported). Concomitant therapy was not reported. The register nurse informed that in approximately 1990 (also reported as "when the patient was 15 years"), the patient experienced peripheral swelling, reported as "her arm swelled up", and she was sent home from school, the peripheral swelling went down. The register nurse also stated "this Fall (2014)" the patient received FLUMIST on an unspecified date and went on an unspecified steroids (after a phone call to an unspecified allergist) because of her asthma. Also stated that the patient recovered in a couple of weeks. The patient sought medical attention calling an unspecified allergist. The outcome of peripheral swelling was reported as recovered/resolved. The reporter considered the event peripheral swelling to be life threatening. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Peripheral swelling
Clinical narrative: Large swelling to the upper arm.
Age: 12.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Local swelling
Clinical narrative: Large swelling to the upper arm.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. On 29-JAN-2015 the patient was inadvertently administered an expired dose of M-M-R II (expiration date: 09-JAN-2015). No adverse effects were noted. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Inflammation, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Red and sore arm around injection site, inflammation, ? cellulitis. Ice packs, antibiotics.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Malaise, Pruritus, Swelling, Urticaria
Clinical narrative: Very swollen felt arm very red hives (2nd yr. in row) itchy. Today feel sick but my physician was very definite that I needed to get this vaccine.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse (LVN) refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. On 19-MAR-2015 the patient was vaccinated with an improperly stored dose of VARIVAX (Merck), 0.5 ml, subcutaneously (dose series, batch/lot # and expiration date not reported). No adverse effects were reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Hyperhidrosis
Clinical narrative: Arthralgia and chills and sweating as well.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia, Skin warm
Clinical narrative: Patient complained of heat and tingling of skin on right side of chest. No rash present.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning an unspecified patient of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored Oral, ROTATEQ Lot number K005396, expiration date: 28-FEB-2016. Concomitant medications were not reproted. No adverse effects were reported and there was no product quality complaint involved. Follow up information has been received from the reporting nurse on 09-MAR-2015, who was available to provide the lot number and expiration date of the vaccine. The reporter also stated that the patient identification information was not available at the time of the call. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: FLUX
Symptoms: Acute respiratory distress syndrome, Asthma, Condition aggravated, Exposure during pregnancy, Influenza
Clinical narrative: Case number PHHY2015US039675, is an initial literature case report received on 26 Mar 2015. The author in the article discussed about pregnancy and severe influenza infection in the 2013/2014 influenza season. This report refers to a 21-year-old female pregnant patient. The patient's current conditions included controlled asthma. The patient's obstetric history included gravida 2 and para 1. No concomitant medication was reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. It was reported that the patient was vaccinated during pregnancy at least two weeks before the onset of symptoms. The patient was evaluated in an outpatient setting for respiratory symptoms and received outpatient care before hospitalization. Five days after the onset of the symptoms the patient received antiviral treatment. On an unknown date (after vaccination) at 21 weeks of gestation, the patient experienced pneumonia, acute respiratory distress syndrome and asthma exacerbation. The patient was hospitalized and was placed on mechanical ventilation. Patient's laboratory results confirmed positive for influenza A infection by polymerase chain reaction (PCR) but the non PCR laboratory result (rapid influenza diagnostic test or direct fluorescent antibody) was negative. The patient had no microbiologic evidence of a bacterial co-infection. The patient was in the hospital for 24 days and later the patient was discharged to home. The final outcome of the events was not reported. Seriousness of the event "confirmation of influenza A infection by PCR (vaccination failure)" was upgraded based on NVS-IME list. The author stated that influenza remains a significant cause of morbidity and mortality in pregnant and postpartum women. Although vaccination was not 100 percent effective given the higler risk of influenza complications among pregnant and postpartum women, it was incumbent that health care providers and obstetricians provide education and counseling to every pregnant woman about its benefits for both mother and neonate. The author concluded that most of the pregnant women in the current literature case series had previously given birth; suggesting the possibility that other small children in the household could also be a source of transmission. Because influenza vaccination was universally recommended, strategies for reducing transmission in pregnant and postpartum women should include vaccination of the entire household unit; likewise, early initiation of antiviral treatment in infected household members who may have close contact with pregnant and postpartum women should be considered.
Age: 21.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza A virus test positive, Laboratory test abnormal, Mechanical ventilation, Pneumonia, Polymerase chain reaction
Clinical narrative: Case number PHHY2015US039675, is an initial literature case report received on 26 Mar 2015. The author in the article discussed about pregnancy and severe influenza infection in the 2013/2014 influenza season. This report refers to a 21-year-old female pregnant patient. The patient's current conditions included controlled asthma. The patient's obstetric history included gravida 2 and para 1. No concomitant medication was reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. It was reported that the patient was vaccinated during pregnancy at least two weeks before the onset of symptoms. The patient was evaluated in an outpatient setting for respiratory symptoms and received outpatient care before hospitalization. Five days after the onset of the symptoms the patient received antiviral treatment. On an unknown date (after vaccination) at 21 weeks of gestation, the patient experienced pneumonia, acute respiratory distress syndrome and asthma exacerbation. The patient was hospitalized and was placed on mechanical ventilation. Patient's laboratory results confirmed positive for influenza A infection by polymerase chain reaction (PCR) but the non PCR laboratory result (rapid influenza diagnostic test or direct fluorescent antibody) was negative. The patient had no microbiologic evidence of a bacterial co-infection. The patient was in the hospital for 24 days and later the patient was discharged to home. The final outcome of the events was not reported. Seriousness of the event "confirmation of influenza A infection by PCR (vaccination failure)" was upgraded based on NVS-IME list. The author stated that influenza remains a significant cause of morbidity and mortality in pregnant and postpartum women. Although vaccination was not 100 percent effective given the higler risk of influenza complications among pregnant and postpartum women, it was incumbent that health care providers and obstetricians provide education and counseling to every pregnant woman about its benefits for both mother and neonate. The author concluded that most of the pregnant women in the current literature case series had previously given birth; suggesting the possibility that other small children in the household could also be a source of transmission. Because influenza vaccination was universally recommended, strategies for reducing transmission in pregnant and postpartum women should include vaccination of the entire household unit; likewise, early initiation of antiviral treatment in infected household members who may have close contact with pregnant and postpartum women should be considered.
Age: 21.0
Sex: F
Vaccine: FLUX
Symptoms: Respiratory disorder, Vaccination failure
Clinical narrative: Case number PHHY2015US039675, is an initial literature case report received on 26 Mar 2015. The author in the article discussed about pregnancy and severe influenza infection in the 2013/2014 influenza season. This report refers to a 21-year-old female pregnant patient. The patient's current conditions included controlled asthma. The patient's obstetric history included gravida 2 and para 1. No concomitant medication was reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. It was reported that the patient was vaccinated during pregnancy at least two weeks before the onset of symptoms. The patient was evaluated in an outpatient setting for respiratory symptoms and received outpatient care before hospitalization. Five days after the onset of the symptoms the patient received antiviral treatment. On an unknown date (after vaccination) at 21 weeks of gestation, the patient experienced pneumonia, acute respiratory distress syndrome and asthma exacerbation. The patient was hospitalized and was placed on mechanical ventilation. Patient's laboratory results confirmed positive for influenza A infection by polymerase chain reaction (PCR) but the non PCR laboratory result (rapid influenza diagnostic test or direct fluorescent antibody) was negative. The patient had no microbiologic evidence of a bacterial co-infection. The patient was in the hospital for 24 days and later the patient was discharged to home. The final outcome of the events was not reported. Seriousness of the event "confirmation of influenza A infection by PCR (vaccination failure)" was upgraded based on NVS-IME list. The author stated that influenza remains a significant cause of morbidity and mortality in pregnant and postpartum women. Although vaccination was not 100 percent effective given the higler risk of influenza complications among pregnant and postpartum women, it was incumbent that health care providers and obstetricians provide education and counseling to every pregnant woman about its benefits for both mother and neonate. The author concluded that most of the pregnant women in the current literature case series had previously given birth; suggesting the possibility that other small children in the household could also be a source of transmission. Because influenza vaccination was universally recommended, strategies for reducing transmission in pregnant and postpartum women should include vaccination of the entire household unit; likewise, early initiation of antiviral treatment in infected household members who may have close contact with pregnant and postpartum women should be considered.
Age: 22.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Caesarean section, Foetal exposure during pregnancy, Premature baby
Clinical narrative: Mother case: Case number PHHY2015US039048, is an initial literature case report received on 26 Mar 2015. The author in the article discussed about the pregnancy and severe influenza infection in the 2013/2014 influenza season. This report refers to a 22-year-old female pregnant patient. The patient's current conditions included congenital neutropenia, hypertension and recurrent skin abscesses. The patient's obstetric history included gravida 2 and para 1. The patient was on prenatal care. No concomitant medication was reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. It was reported that the patient was vaccinated during pregnancy at least two weeks before the onset of symptoms. The patient was evaluated in an outpatient setting for respiratory symptoms and received outpatient care before hospitalization. Four days after the onset of the symptoms the patient received antiviral treatment. On an unknown date (after vaccination) at 32 weeks of gestation, the patient experienced neutropenic fever, pneumonia and sepsis. The patient had an emergent cesarean delivery on admission to alleviate maternal hypoxia and delivered neonate at a gestational age of 32 weeks (see child case: PHHY2015US038994). The patient required hemodialysis for acute renal failure, intravenous pressors for low blood pressure and was placed on mechanical ventilation. The outcome of the events neutropenic fever, acute renal failure, pneumonia, low blood pressure, maternal hypoxia and sepsis was not reported. Patient's laboratory results confirmed positive for influenza A infection by polymerase chain reaction (PCR) and subtyped as pH1N1. The patient had no microbiologic evidence of a bacterial co-infection. The patient was in the hospital for seven days and the patient died in the hospital. Seriousness of the event "confirmation of influenza A infection by polymerase chain reaction (PCR) and subtyped as pH1N1 (vaccination failure)" was upgraded based on NVS-IME list. The author stated that influenza remains a significant cause of morbidity and mortality in pregnant and postpartum women. Although vaccination was not 100 percent effective given the higher risk of influenza complications among pregnant and postpartum women, it was incumbent that health care providers and obstetricians provide education and counseling to every pregnant woman about its benefits for both mother and neonate. The author concluded that most of the pregnant women in the current literature case series had previously given birth, suggesting the possibility that other small children in the household could also be a source of transmission. Because influenza vaccination was universally recommended, strategies for reducing transmission in pregnant and postpartum women should include vaccination of the entire household unit; likewise, early initiation of antiviral treatment in infected household members who may have close contact with pregnant and postpartum women should be considered.
Age: 22.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Respiratory disorder, Sepsis, Vaccination failure
Clinical narrative: Mother case: Case number PHHY2015US039048, is an initial literature case report received on 26 Mar 2015. The author in the article discussed about the pregnancy and severe influenza infection in the 2013/2014 influenza season. This report refers to a 22-year-old female pregnant patient. The patient's current conditions included congenital neutropenia, hypertension and recurrent skin abscesses. The patient's obstetric history included gravida 2 and para 1. The patient was on prenatal care. No concomitant medication was reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. It was reported that the patient was vaccinated during pregnancy at least two weeks before the onset of symptoms. The patient was evaluated in an outpatient setting for respiratory symptoms and received outpatient care before hospitalization. Four days after the onset of the symptoms the patient received antiviral treatment. On an unknown date (after vaccination) at 32 weeks of gestation, the patient experienced neutropenic fever, pneumonia and sepsis. The patient had an emergent cesarean delivery on admission to alleviate maternal hypoxia and delivered neonate at a gestational age of 32 weeks (see child case: PHHY2015US038994). The patient required hemodialysis for acute renal failure, intravenous pressors for low blood pressure and was placed on mechanical ventilation. The outcome of the events neutropenic fever, acute renal failure, pneumonia, low blood pressure, maternal hypoxia and sepsis was not reported. Patient's laboratory results confirmed positive for influenza A infection by polymerase chain reaction (PCR) and subtyped as pH1N1. The patient had no microbiologic evidence of a bacterial co-infection. The patient was in the hospital for seven days and the patient died in the hospital. Seriousness of the event "confirmation of influenza A infection by polymerase chain reaction (PCR) and subtyped as pH1N1 (vaccination failure)" was upgraded based on NVS-IME list. The author stated that influenza remains a significant cause of morbidity and mortality in pregnant and postpartum women. Although vaccination was not 100 percent effective given the higher risk of influenza complications among pregnant and postpartum women, it was incumbent that health care providers and obstetricians provide education and counseling to every pregnant woman about its benefits for both mother and neonate. The author concluded that most of the pregnant women in the current literature case series had previously given birth, suggesting the possibility that other small children in the household could also be a source of transmission. Because influenza vaccination was universally recommended, strategies for reducing transmission in pregnant and postpartum women should include vaccination of the entire household unit; likewise, early initiation of antiviral treatment in infected household members who may have close contact with pregnant and postpartum women should be considered.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Chronic pigmented purpura
Clinical narrative: Onset of Pigmented Purpura reported in patient's left leg from ankle to mid thigh.  Unresolved at this time.
Age: 35.0
Sex: M
Vaccine: FLU4, HEPAB, TYP
Symptoms: Pain in extremity
Clinical narrative: Experienced right foot pain then next day 04/03/2015 experienced left foot pain.  Both feet painful to walk on 04/03/15, 04/04/2015, 04/05/2015, and 04/06/2015. On 04/06/2015 pain in both feet is less severe.
Age: 30.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site reaction, Pharyngeal oedema, Rash, Rash pruritic
Clinical narrative: Throat swelling, itchy rash on chest arms and back, and 9mm x 4mm rash around the injection site.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PPV
Symptoms: Conjunctivitis, Cough, Ear infection, Nasal congestion, Nasopharyngitis
Clinical narrative: 3/25 fever started.  Treated with alternating infant Tylenol and infant Advil every 3 hours.  Fever lasted 9 days on and off.  Runny/stuffy nose and cough (cold) started 3/26.  Rash started 3/29.  Pink eye started 4/1/15.  Taken to urgent care on 4/1/15.  Diagnosed with pink eye and double ear infection.  On 4/2 the rash seemed better, but on 4/4 it was worse, then looked better again on 4/5.  On 4/6 she still has a small rash, stuffy/runny nose.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PPV
Symptoms: Pyrexia, Rash, Rhinorrhoea
Clinical narrative: 3/25 fever started.  Treated with alternating infant Tylenol and infant Advil every 3 hours.  Fever lasted 9 days on and off.  Runny/stuffy nose and cough (cold) started 3/26.  Rash started 3/29.  Pink eye started 4/1/15.  Taken to urgent care on 4/1/15.  Diagnosed with pink eye and double ear infection.  On 4/2 the rash seemed better, but on 4/4 it was worse, then looked better again on 4/5.  On 4/6 she still has a small rash, stuffy/runny nose.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Cough, Ear infection, Feeling cold, Headache
Clinical narrative: Cold chills, Fever chills. Actual Fever over 102. Headache. Aperiodic sweating. Malaise. Day 2-3 Cough, Runny nose, Upper respiratory cold.  Common cold symptoms turned to ear/sinus infection. More anatomical- patient related. Con't cold chills for several months. Feet could not stay warm.  Persistent cold last over 2 months.  Prolonged time off work. Inability to be out in the cold. Full body chills for months after.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Hyperhidrosis, Impaired work ability, Malaise, Nasopharyngitis, Peripheral coldness
Clinical narrative: Cold chills, Fever chills. Actual Fever over 102. Headache. Aperiodic sweating. Malaise. Day 2-3 Cough, Runny nose, Upper respiratory cold.  Common cold symptoms turned to ear/sinus infection. More anatomical- patient related. Con't cold chills for several months. Feet could not stay warm.  Persistent cold last over 2 months.  Prolonged time off work. Inability to be out in the cold. Full body chills for months after.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Rhinorrhoea, Sinusitis, Temperature intolerance
Clinical narrative: Cold chills, Fever chills. Actual Fever over 102. Headache. Aperiodic sweating. Malaise. Day 2-3 Cough, Runny nose, Upper respiratory cold.  Common cold symptoms turned to ear/sinus infection. More anatomical- patient related. Con't cold chills for several months. Feet could not stay warm.  Persistent cold last over 2 months.  Prolonged time off work. Inability to be out in the cold. Full body chills for months after.
Age: 31.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Exposure during pregnancy, Ultrasound antenatal screen normal
Clinical narrative: Pt unknowingly pregnant at time of vaccination - estimated date of conception 13 Feb 2015 per ultrasound from 30 Mar 2015.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Decreased appetite, Injection site rash, Rash
Clinical narrative: Rash on left leg at injection site and right foot. Loss of appetite. Dr. informed to take Benadryl for the next few days until rash is gone.
Age: 33.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Gave pediactric dose of Hep A.
Age: 55.0
Sex: M
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Impaired work ability, Injection site pain, Myalgia
Clinical narrative: Fever >102F, myalgias, headache, chills, and site soreness. Unable to go to work.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Fever >102F, myalgias, headache, chills, and site soreness. Unable to go to work.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: 4/3/15 - sensitive/sore at injection site. 4/4/15- red, inflammation, pain, warm and itchy at injection site, about 3 inches wide. Ibuprofen 400 mg taken with no relief. Denied fever. Advised to delineate border w new sharpie to ensure eyrthema not expanding.  Encourage Benadryl 25-50mg PO q 6 hours x 2 days, Motrin 400mg PO TID prn, and an ice pack.
Age: 11.0
Sex: M
Vaccine: HPVX
Symptoms: Dyskinesia, Pyrexia, Syncope
Clinical narrative: Fainting followed by body jerking movements and a fever.
Age: 68.0
Sex: F
Vaccine: PPV, TYP
Symptoms: Hyperhidrosis, Inflammation, Injection site cellulitis, Pain in extremity, Pyrexia
Clinical narrative: Patient developed cellulitis at injection site.  70% of the arm with inflamed. Patient experienced fever, sweating, and aching arm.