chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a nurse practitioner via a company representative refers to a 68 year old female patient. Patients medical history was unspecified. On an unknown date the patient was vaccinated with PNEUMOVAX23 (lot #, expiry date, dose and route of administration unknown, reported as 'as directed by physician') after an angiogram was performed. Concomitant medication included a lot of unspecified medications. It was reported that the patient experienced redness and swelling in the arm and developed a temperature of 100F. It was reported that there was pain and discomfort in the arm (disability). The patient sought medical attention and visited physicians office. She was told to take BENADRYL, TYLENOL and use cold compress on the arm. There was no intervention to prevent pain and discomfort to the arm. The outcome of redness and swelling in the arm, developed a temperature of 100F and redness and swelling of the arm was reported as recovering. The causality of the event with suspect product was unknown. There was no product quality complaint. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Death neonatal, Foetal exposure during pregnancy, Neonatal asphyxia, Sudden infant death syndrome, Varicella
Clinical narrative: This spontaneous report was received from a consumer (mother) refers to a 7 weeks and 2 days old male patient. On an unknown date in November 1998 the patient's mother was vaccinated with varicella virus vaccine live (manufacturer unknown) dose 1. The child was exposed to the suspect vaccine in utero when the mother was 5.5 months pregnant. On an unspecified date in 1998 the patient developed chicken pox in utero and was born with chicken pox on an unspecified date. On an unknown date in 1999 the patient passed away due to affixation/sudden infant death syndrome (SIDS) (death), when he was 7 weeks and 2 days old. The outcome of affixation/SIDS was reported as fatal. The outcome of drug exposure in utero, born with chicken pox and developed chicken pox in utero was unknown. The reporter considered developed chicken pox in utero, affixation/SIDS and born with chicken pox to be related to varicella virus vaccine live (manufacturer unknown). This case is linked to case # 1401USA014406, # 1401USA014557 and case # 1401USA014599 via parent-child link. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report was received from a consumer (mother) refers to a 7 weeks and 2 days old male patient. On an unknown date in November 1998 the patient's mother was vaccinated with varicella virus vaccine live (manufacturer unknown) dose 1. The child was exposed to the suspect vaccine in utero when the mother was 5.5 months pregnant. On an unspecified date in 1998 the patient developed chicken pox in utero and was born with chicken pox on an unspecified date. On an unknown date in 1999 the patient passed away due to affixation/sudden infant death syndrome (SIDS) (death), when he was 7 weeks and 2 days old. The outcome of affixation/SIDS was reported as fatal. The outcome of drug exposure in utero, born with chicken pox and developed chicken pox in utero was unknown. The reporter considered developed chicken pox in utero, affixation/SIDS and born with chicken pox to be related to varicella virus vaccine live (manufacturer unknown). This case is linked to case # 1401USA014406, # 1401USA014557 and case # 1401USA014599 via parent-child link. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (Was worse, getting better) hot and swollen and very sore at injection site started swelling at home after spending 15 min. in store (pt. said she had shot 4-5 years ago, couldn't remember and had no reaction to it) told her to take BENADRYL, TYLENOL, and warm compress and go to MD if stops getting better or gets worse.
Age: 39.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Breast operation, Corneal lesion, Eczema, Exposure during pregnancy, Hysterectomy
Clinical narrative: This spontaneous retrospective pregnancy report was received from a 39 year old female other health professional reporting on herself. Patient had a history of allergy to TORADOL and allergy to sulfa drugs. Patient had a history of previous pregnancy in 1998. On an unknown date in November 1998, the patient was vaccinated with VARIVAX (manufacturer unknown). No concomitant medications were reported. The patient became pregnant on an unspecified date. The last menstrual period and estimated date of delivery were not reported. It was reported that the patient had twins who were 2 weeks apart in utero. The patient delivered twins of unkonwn gender on an unspecified date. The pregnancy outcome was live birth. It was reported that the pregnancy was followed by menometrorrhagia. The outcome of menometrorrhagia was unknown. The causality of the event in relation to vaccination with VARIVAX (manufacturer unknown) was not reported. This case is linked to case #1401USA014406 and #1401USA014599 via the same patient link and to case #1401USA014558 via the parent child link. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Immediate post-injection reaction, Intraocular pressure increased, Laboratory test, Menometrorrhagia, Neonatal disorder
Clinical narrative: This spontaneous retrospective pregnancy report was received from a 39 year old female other health professional reporting on herself. Patient had a history of allergy to TORADOL and allergy to sulfa drugs. Patient had a history of previous pregnancy in 1998. On an unknown date in November 1998, the patient was vaccinated with VARIVAX (manufacturer unknown). No concomitant medications were reported. The patient became pregnant on an unspecified date. The last menstrual period and estimated date of delivery were not reported. It was reported that the patient had twins who were 2 weeks apart in utero. The patient delivered twins of unkonwn gender on an unspecified date. The pregnancy outcome was live birth. It was reported that the pregnancy was followed by menometrorrhagia. The outcome of menometrorrhagia was unknown. The causality of the event in relation to vaccination with VARIVAX (manufacturer unknown) was not reported. This case is linked to case #1401USA014406 and #1401USA014599 via the same patient link and to case #1401USA014558 via the parent child link. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Nodule, Pneumonia, Skin disorder, Thyroid disorder, Varicella post vaccine
Clinical narrative: This spontaneous retrospective pregnancy report was received from a 39 year old female other health professional reporting on herself. Patient had a history of allergy to TORADOL and allergy to sulfa drugs. Patient had a history of previous pregnancy in 1998. On an unknown date in November 1998, the patient was vaccinated with VARIVAX (manufacturer unknown). No concomitant medications were reported. The patient became pregnant on an unspecified date. The last menstrual period and estimated date of delivery were not reported. It was reported that the patient had twins who were 2 weeks apart in utero. The patient delivered twins of unkonwn gender on an unspecified date. The pregnancy outcome was live birth. It was reported that the pregnancy was followed by menometrorrhagia. The outcome of menometrorrhagia was unknown. The causality of the event in relation to vaccination with VARIVAX (manufacturer unknown) was not reported. This case is linked to case #1401USA014406 and #1401USA014599 via the same patient link and to case #1401USA014558 via the parent child link. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Delivery, Exposure during pregnancy, Menometrorrhagia, Twin pregnancy
Clinical narrative: This spontaneous retrospective pregnancy report was received from a 39 year old female other health professional reporting on herself. Patient had a history of allergy to TORADOL and allergy to sulfa drugs. Patient had a history of previous pregnancy in 1998. On an unknown date in November 1998, the patient was vaccinated with VARIVAX (manufacturer unknown). No concomitant medications were reported. The patient became pregnant on an unspecified date. The last menstrual period and estimated date of delivery were not reported. It was reported that the patient had twins who were 2 weeks apart in utero. The patient delivered twins of unkonwn gender on an unspecified date. The pregnancy outcome was live birth. It was reported that the pregnancy was followed by menometrorrhagia. The outcome of menometrorrhagia was unknown. The causality of the event in relation to vaccination with VARIVAX (manufacturer unknown) was not reported. This case is linked to case #1401USA014406 and #1401USA014599 via the same patient link and to case #1401USA014558 via the parent child link. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Presented on 1/31/14 local injection reaction: including - soreness, warmth, swelling, erythema and induration. No fever at this time. Injection site appears to have mild cellulitis, referred to primary care physician.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Local reaction
Clinical narrative: Presented on 1/31/14 local injection reaction: including - soreness, warmth, swelling, erythema and induration. No fever at this time. Injection site appears to have mild cellulitis, referred to primary care physician.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Headache, Malaise, Pain in extremity
Clinical narrative: Patient is describing that her arm is very sore for the past week since the shot. She is feeling very weak with headache, OTC meds are not helping. She states she has never been this sick ever.
Age: 78.0
Sex: M
Vaccine: PPV, TD
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red, warm to the touch 3cm circle on (R) deltoid.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Local reaction, Skin warm, Tenderness
Clinical narrative: 2 days following vaccines, developed red, tender and warm local reaction today 10 x 6 cm, no longer tender, no systemic symptoms.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness, itching at vaccine site 3" in diameter, (L) thigh.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Cough, Malaise, Nasal congestion, Pyrexia, Rash
Clinical narrative: This spontaneous report was received from a 4 year old female patient's mother refers to her daughter. On unknown date the patient was vaccinated with the first dose of M-M-R II (dose, lot# not reported). On 15-JAN-2014 the patient was vaccinated with the second dose of M-M-R II (dose, lot# not reported). On 22-JAN-2014, the reporter experienced widespread facial rash in the form of large welts an the child experienced fever as high as 104 F, stuffy nose, cough, rash and overall malaise. The patient was treated with TYLENOL and MOTRIN. The reporter noted that a "more mild" and unreported reaction, in the form of rash and a lower grade fever, was also experienced by her daughter after the "first dose" of M-M-R II. That first reaction, however, lasted for a shorter duration. At time of reporting, the patient had not recovered from the events which occurred after second dose of M-M-R II. Action taken with M-M-R II was not reported. The patient had sought medical attention. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a 4 year old female patient's mother refers to her daughter. On unknown date the patient was vaccinated with the first dose of M-M-R II (dose, lot# not reported). On 15-JAN-2014 the patient was vaccinated with the second dose of M-M-R II (dose, lot# not reported). On 22-JAN-2014, the reporter experienced widespread facial rash in the form of large welts an the child experienced fever as high as 104 F, stuffy nose, cough, rash and overall malaise. The patient was treated with TYLENOL and MOTRIN. The reporter noted that a "more mild" and unreported reaction, in the form of rash and a lower grade fever, was also experienced by her daughter after the "first dose" of M-M-R II. That first reaction, however, lasted for a shorter duration. At time of reporting, the patient had not recovered from the events which occurred after second dose of M-M-R II. Action taken with M-M-R II was not reported. The patient had sought medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Antisocial behaviour, Back pain, Condition aggravated, General physical health deterioration
Clinical narrative: This spontaneous report as a part of social media received from a Twitter user who refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (lot number, expiration date, dose, route of administration and indication were not reported). It was reported that the patient had matching symptoms to those mentioned in the report with MARRS# 1401USA014506. It was reported that on unspecified date the patient finished the GARDASIL vaccine series, and her health went downhill from there. Her pain just kept getting increasingly worse and it was just spreading further and further throughout her body. It was reported that she has been in pain for years, she was visiting multiple doctors, who gave her pain remedy that did not work, they did not have any explanation for patient's severe back pain or leg pain. She stated that the pain would not go away. It was reported that she could not walk, she could not sleep, she could barely have friends. The patient was on a strict diet and vitamin regimen to cleanse her body. The outcome of the events was unknown. The relatedness between the events and GARDASIL was not reported. This is one of the several reports received from the same source. Upon internal review, the event she could not walk was considered to be disabling. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Insomnia, Pain, Pain in extremity
Clinical narrative: This spontaneous report as a part of social media received from a Twitter user who refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (lot number, expiration date, dose, route of administration and indication were not reported). It was reported that the patient had matching symptoms to those mentioned in the report with MARRS# 1401USA014506. It was reported that on unspecified date the patient finished the GARDASIL vaccine series, and her health went downhill from there. Her pain just kept getting increasingly worse and it was just spreading further and further throughout her body. It was reported that she has been in pain for years, she was visiting multiple doctors, who gave her pain remedy that did not work, they did not have any explanation for patient's severe back pain or leg pain. She stated that the pain would not go away. It was reported that she could not walk, she could not sleep, she could barely have friends. The patient was on a strict diet and vitamin regimen to cleanse her body. The outcome of the events was unknown. The relatedness between the events and GARDASIL was not reported. This is one of the several reports received from the same source. Upon internal review, the event she could not walk was considered to be disabling. Additional information is not expected.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, No adverse event
Clinical narrative: Pt came in for ZOSTAVAX Rx and was given the shot. Pt has hx of Parkinson's (severe). Pt wife came back to say he was having shortness of breath. She decided to take him to Dr. care to be on safe side. Pt was cleared to not having a reaction to the shot but rather symptoms from his condition.
Sex: U
Vaccine: MNQ
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case received from another manufacturer (Merck) through Sanofi's affiliate on 24-Jan-2014. A patient (no details provided), with no reported personal and family medical history and no reported concomitant therapies, had received a dose of MENACTRA (batch number, route and anatomical site of administration not reported) on an unspecified date. On an unspecified date post-vaccination, the patient experienced Guillain-Barre Syndrome. No further information was provided.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. On 24-JAN-2014 the patient was vaccinated with M-M-R II (dose not reported, lot # 1768AA, expired date: 10-NOV-2013). No adverse effects. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a consumer refers to herself as a 66 year old female patient. On an unknown date in January 2012 (also reported as two years ago), the patient was vaccinated with ZOSTAVAX one injection. Concomitant therapies included prednisone. On 17-JAN-2014, the patient experienced feeling symptoms of shingles across her back. The patient sought medical attention. It was also reported that the patient had shingles 10 years or 5 years ago and then got the vaccine 2 years ago. The outcome of feeling symptoms of shingles across her back was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with ZOSTAVAX (dosing regimen and frequency unknown) (lot number and expiry date unknown). No concomitant medications were reported. On an unknown date the patient experienced redness at injection site, hot to touch, feeling of ball under skin and swelling at injection site. The action taken with the therapy with ZOSTAAVAX was unknown. The outcome of feeling of ball under skin, redness at injection site, swelling at injection site and hot to touch was unknown. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality issue reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a healthcare professional for GARDASIL, a Pregnancy Registry product, concerning refers to a 22 year old female patient. The patient had a history of 3 previous pregnancies and 2 live birth(s) of 39 weeks both, no preterm deliveries, no spontaneous abortion, no elective terminations and no fetal deaths were reported. There were no birth defects in previous pregnancies and no complications in previous pregnancies. On 04-DEC-2013, the patient was vaccinated with the third dose of GARDASIL, lot # J006850, expiration date 31-MAR-2016 (route was not provided). The patient's last menstrual period was on 05-NOV-2013 and the estimated delivery date would be on 12-AUG-2014. The pregnancy outcome was unknown. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to a 14 year old unknown gender patient. On 29-JUL-2013 the patient was vaccinated with GARDASIL injection, first dose (lot number and expiry date unspecified) 0.5 ml, intramuscularly. On 30-OCT-2013, second dose of GARDASIL with lot 1745AA expiry date 13-SEP-2014 was administered and no adverse events were reported. The outcome of the event was reported as unknown. This case # 1401USA014551 is linked with case # 1402USA000389 via same reporter link. Additional information has been requested.
Age: 23.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received form registered nurse refers to a 23 year old unknown gender patient. On 08-JUL-2013 the patient was vaccinated with GARDASIL injection, first dose (lot number and expiry date unspecified), 0.5 ml, intramuscularly. On 18-OCT-2013, second dose of GARDASIL with lot 1745AA expiry date 13-SEP-2014 was administered and no adverse events were reported. The outcome of the event was reported as unknown. This case # 1402USA000389 is linked with case # 1401USA014451 via same reporter link. Additional information has been requested.
Age: 1.72
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 20 month old patient of unknown gender. On 29-AUG-2008 the patient was vaccinated with first dose of M-M-R II (dosing regimen and frequency unknown) (lot number and expiry date unknown) 0.5ml subcutaneously. No concomitant medications were reported. On 01-APR-2009, the patient received second dose of M-M-R II since the office was not aware that the patient had received the first dose on 29-AUG-2008. No adverse event was reported. The action taken with the therapy with M-M-R II was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 29-JAN-2014 the patient was vaccinated with a dose of ZOSTAVAX with an expiry date of 17-JAN-2014 (lot number unknown) (route and dosing regimen unknown). No adverse events were reported. The action taken with the therapy with ZOSTAVAX was unknown. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Rash, Rash maculo-papular
Clinical narrative: Developed lt upper arm pain and swelling on1/26/14. Lt upper arm rash 1/28/14. Maculopapular rash to abdomen and chest 1/29/14. 1/31/14 states abd rash resolved, chest lesions crusted over lt arm improving.
Age: 30.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Scab, Skin lesion
Clinical narrative: Developed lt upper arm pain and swelling on1/26/14. Lt upper arm rash 1/28/14. Maculopapular rash to abdomen and chest 1/29/14. 1/31/14 states abd rash resolved, chest lesions crusted over lt arm improving.
Age: 20.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 20 year old patient. On 08-JAN-2014 the patient might be vaccination with VARIVAX (merck), 0.5 ml (lot# reported as J004817, expired date 18-APR-2015), subcutaneously. It was reported that VARIVAX (merck) had been stored in refrigerator for approximately two days after prior temperature excursion of -5C for 90 hours. The reporter confirmed later that VARIVAX (merck) only went out of range once and it was supported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician (M.D.) refers to a patient of unkonwn age. On an unknown date of "last week" (January 2014) the patient was vaccinated with a dose of VARIVAX (Merck) (dose, route, frequency, injection site and lot# not provided). It was reported that an unspecified patient, of a different unspecified physician within in reporter's practice, was mistakenly administered a dose of VARIVAX (Merck) instead of ZOSTAVAX on an unspecified date "last week" (January 2014). No adverse effect reported. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 60 year old female patient. On an unknown date in January 2014, the patient was vaccinated with ZOSTAVAX standard dose. On an unknown date in January 2014 (also reported as 2-3 weeks ago), the patient experienced ophthalmic shingles. The patient sought medical attention and visited the physician office for treatment. The patient was treated with VALTREX. The outcome of the event ophthalmic shingles was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from registered nurse refers to a 25 year old female patient. Patient had no previous medical history and drug allergies. On 07-OCT-2013 the patient was vaccinated with GARDASIL injection lot # J007354 with expiry date 20-FEB-2016, 0.5 ml, intramuscularly. Concomitant therapies included unspecified birth control. On 11-OCT-2013, 4 days after receiving GARDASIL the patient developed a sore arm. On 11-OCT-2013, patient notified nurse via phone and no treatment was given. No laboratory tests were performed. The outcome of sore arm was unknown. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a physician refers to a 20 year old female patient. On 12-DEC-2013, the patient was vaccinated with GARDASIL, 0.5 ml, intramuscular. On an unknown date in December 2013 (also reported as before 25-DEC-2013), the patient experienced rash that looked like bug bites on her face and other unspecified areas of her body. The patient sought medical attention and was seen by the physician on an unknown date. Other suspect drug included DEPO-PROVERA (also reported as DEPO shot), which was administered the same day as the GARDASIL was administered. The outcome of the event rash on her face and other unspecified areas of her body were unknown. The reporter did not provide the causality between the events and the suspect drug. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 16-JAN-2014 the patient was vaccinated with a dose of PROQUAD (Merck) (lot # H015789, Exp date: 24-FEB-2014), 0.5 ml, subcutaneously. Other suspect therapy included VARIVAX (Merck) (lot # reported as H016717), 0.5 ml, subcutaneously. No adverse effects reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician refers to a 70 year old female patient. On an unknown date in the year 2011 (also reported as about three years ago), the patient was vaccinated with ZOSTAVAX. On 28-JAN-2014, the patient experienced shingles. On 28-JAN-2014, the patient sought medical attention and was seen by the patient. The outcome of the event shingles was reported as not recovered. The reporter did not provide the causality between the event and the suspect drug. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Inappropriate schedule of drug administration, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient had swelling and warmth in area. Also felt tired and feverish. Dr. told her to ice and notified her that she already got vaccine in 8/2013.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Exposure during pregnancy, Local swelling, Pain, Pain in extremity
Clinical narrative: Pt had vaccine on 1/15/2014. She was administered the Tdap vaccine. She called on 1/17/2014, and said she woke up to her arm swollen, red, throbbing, and bumpy. She is 8 months pregnant.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Pt had vaccine on 1/15/2014. She was administered the Tdap vaccine. She called on 1/17/2014, and said she woke up to her arm swollen, red, throbbing, and bumpy. She is 8 months pregnant.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness
Clinical narrative: Arm and neck was stiff and unable to use. Lasted approx. 2 days. Treated with NSAIDs.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Movement disorder, Pain in extremity
Clinical narrative: Patient reports experiencing severe arm pain for 2 days of which he could not lift his arm. Patient denies signs or symptoms of shortness of breath, or rash or hives.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Rt upper thigh injection site with 9 cm x 7 cm oval area of firm redness. (KINRIX injection site). Treated with BENADRYL every 6-8 hrs.
Age: 17.0
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Expired drug administered
Clinical narrative: Vaccine expired 1/20/2014; looked at vial but must not have registered the date - until writing down after given.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Pain in site area, difficulty lifting arm, pain meds, physical therapy, symptoms still continue.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling, Vomiting
Clinical narrative: Swelling at site of injection site left vastus lateralis - vomiting.
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: This is one case out of a cumulative total of 223 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 24 January 2014. These 223 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 24 January 2014 from the Investigator participating in a study under reference number M5A16. A case of pertussis disease in a seven-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received three doses of PENTACEL on 16 July 2013 (lot number C4487AA), 16 September 2013 (lot number C4486AA), and 22 November 2013 (lot number C4559AA) (routes and site of administration not reported). The subject developed catarrhal illness and cough on 21 December 2013, 29 days after the last dose, and on 28 January 2014 developed a paroxysmal cough without a whoop. She also experienced post-tussive vomiting, apnea and sleep disturbance. Laboratory testing included a positive PCR on 31 December 2013; a chest X-ray was negative. Corrective treatment included azithromycin for 5 days beginning 04 January 2014. The subject was not hospitalized. At the time of final contact on 06 January 2014 the subject's cough was still ongoing. The duration of the cough was reported at that time as 16 days. Investigator causality assessment is not required as per the protocol. Documents held by sender: None.
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Pertussis, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 223 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 24 January 2014. These 223 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 24 January 2014 from the Investigator participating in a study under reference number M5A16. A case of pertussis disease in a seven-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received three doses of PENTACEL on 16 July 2013 (lot number C4487AA), 16 September 2013 (lot number C4486AA), and 22 November 2013 (lot number C4559AA) (routes and site of administration not reported). The subject developed catarrhal illness and cough on 21 December 2013, 29 days after the last dose, and on 28 January 2014 developed a paroxysmal cough without a whoop. She also experienced post-tussive vomiting, apnea and sleep disturbance. Laboratory testing included a positive PCR on 31 December 2013; a chest X-ray was negative. Corrective treatment included azithromycin for 5 days beginning 04 January 2014. The subject was not hospitalized. At the time of final contact on 06 January 2014 the subject's cough was still ongoing. The duration of the cough was reported at that time as 16 days. Investigator causality assessment is not required as per the protocol. Documents held by sender: None.
Age: 25.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Dyspnoea, Dyspnoea exertional, Electrocardiogram normal, Troponin I normal
Clinical narrative: This study case was received from the investigator in a trial on 23 January 2014. A 25 year-old male subject had received on 06 January 2014 the following vaccines: ACAM2000 (lot number, route and of administration not reported), anthrax (manufacturer, lot number, route and site of administration not reported) and typhoid (manufacturer, lot number, route, and site of administration not reported) and seven days later, experienced shortness of breath one time during exercise. On 14 January 2014, the subject had a normal troponin and a normal ECG. According to the investigator, cardiac etiology could not be ruled out and the subject was referred appropriately, no further information was expected to follow. Actions taken were none. Outcome was recovered on 13 January 2014. According to the investigator, the event of shortness of breath was considered mild, an "other important event" and possibly related to vaccination. Documents held by sender: none.
Age: 24.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Exposure during pregnancy, Influenza like illness, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to approximately 24 year old female patient. The patient's pertinent medical history included anxiety, drug reactions/allergies to sulfa. On 04-OCT-2013 the patient was vaccinated with a dose of GARDASIL (lot: J003727; expiration: 07-NOV-2015 (also reported as unspecified) and on 10-JAN-2014 (lot: J012212; expiration: 18-FEB-2016 (also reported as unspecified), intramuscular. The patient also received FLUZONE (manufacturer unspecified) on 10-JAN-2014. Concomitant therapies included CELEXA and NORCO. The patient became pregnant with last menstrual period (LMP) of 10-DEC-2013 and estimated delivery date (EDD) of approximately 16-SEP-2014. The patient was confirmed as pregnant by a blood pregnancy test performed on 29-JAN-2014. Trimester exposure to GARDASIL was at first trimester. The pregnancy outcome was pending. On 11-JAN-2014, the patient experienced flu-like symptoms. No treatment received for the event; however, the patient sought medical attention. The event flu-like symptoms were recovered on 29-JAN-2014. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature decreased, Dyspnoea, Feeling cold, Heart rate abnormal, Lung disorder
Clinical narrative: 2 hours after vaccine take, my throat started to swell, my left lung felt like it had collapsed. My heart rate was out of control and I couldn't breathe. My temperature was low and I started to be freezing cold. My throat felt like I swallowed a huge object comparing to a apple or peach. I took a 81 mg Aspirin and took a hot bath.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Sensation of foreign body
Clinical narrative: 2 hours after vaccine take, my throat started to swell, my left lung felt like it had collapsed. My heart rate was out of control and I couldn't breathe. My temperature was low and I started to be freezing cold. My throat felt like I swallowed a huge object comparing to a apple or peach. I took a 81 mg Aspirin and took a hot bath.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Chest pain, Electrocardiogram normal, Myopericarditis, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 23 January 2014. A 24 year-old male subject had received the following vaccines on 07 January 2014: ACAM2000 (lot number, route and site of administration not reported), anthrax (manufacturer, lot number, route and site of administration not reported) and typhoid (manufacturer, lot number, route and site of administration not reported). On 13 and 14 January 2014, the subject experienced two episodes of chest pain during exercise. The subject took ibuprofen per os once prior to physical training on unspecified date. On 14 January 2014, the subject had a normal Troponin and on 15 January 2014 had a normal ECG. The subject was referred appropriately as myopericarditis could not be ruled out. No further information was available at the time of the report. The subject's outcome was recovered. According to the investigator, the event of chest pain was considered mild, an "other important event" and possibly related to vaccination. Documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Nausea, Vomiting
Clinical narrative: Vaccine administered 1/3/2014, within 96 hours patient experienced extreme vomiting, nausea and vomiting that lasted 7 days.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Vaccine (Quadrivalent flu vaccine) administered 1/6/14. Patient experienced severe nausea vomiting, diarrhea that lasted 6 to 7 day.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling, Pain in extremity
Clinical narrative: Patient called, stated her right arm was painful and swollen in the area where she got her chicken pox vaccine.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Migraine, Pyrexia, Tremor
Clinical narrative: Shakes, fever, chills, migraine.
Age: 64.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Erythema, Swelling
Clinical narrative: Redness, swelling.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram normal, Movement disorder, Pain in extremity
Clinical narrative: Reported arm soreness that has not resolved in over 2 weeks. Currently hurts less in the morning but gets worse as day goes on with activity. Gets to the point where she has trouble lifting her arm by end of day. MD ordered EMG to check for nerve damage.
Age: 1.28
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis
Clinical narrative: This is one case out of a cumulative total of 224 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 24 January 2014. These 224 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 24 January 2014 from the Investigator participating in a study under reference number M5A16. A case of pertussis disease in a three-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of PENTACEL (lot numbers not reported) on 12 August 2010, 12 October 2010, 10 December 2010, and 19 September 2011 (routes and site of administration not reported). The subject developed a cough on 26 December 2013, approximately two years and three months after the last dose, and on 07 January 2014 developed a paroxysmal cough without a whoop. He also experienced apnea and sleep disturbance. Laboratory testing included a positive PCR on 04 January 2014; a chest x-ray was negative. Corrective treatment included azithromycin for 5 days. The subject was not hospitalized. At the time of final contact on 15 January 2014 the subject's cough had resolved. The duration of the cough was reported at that time as 18 days. Investigator causality assessment is not required as per the protocol. Documents held by sender: None.
Age: 1.28
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 224 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 24 January 2014. These 224 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 24 January 2014 from the Investigator participating in a study under reference number M5A16. A case of pertussis disease in a three-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of PENTACEL (lot numbers not reported) on 12 August 2010, 12 October 2010, 10 December 2010, and 19 September 2011 (routes and site of administration not reported). The subject developed a cough on 26 December 2013, approximately two years and three months after the last dose, and on 07 January 2014 developed a paroxysmal cough without a whoop. He also experienced apnea and sleep disturbance. Laboratory testing included a positive PCR on 04 January 2014; a chest x-ray was negative. Corrective treatment included azithromycin for 5 days. The subject was not hospitalized. At the time of final contact on 15 January 2014 the subject's cough had resolved. The duration of the cough was reported at that time as 18 days. Investigator causality assessment is not required as per the protocol. Documents held by sender: None.
Age: 1.46
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Fever, red spotted rash on back, neck, chest, and belly.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Abasia, Arthralgia, Asthenia, Hallucination, Hypoxia
Clinical narrative: 6:00 PM 06/05/2013 Arthralgia, weakness. 9:00 AM 06/06/2013 Weakness, paleness, tachycardia & palpitations. These advanced to hallucinations, fever, severe weakness (unable to walk) & hypoxia.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Pallor, Palpitations, Pyrexia, Tachycardia
Clinical narrative: 6:00 PM 06/05/2013 Arthralgia, weakness. 9:00 AM 06/06/2013 Weakness, paleness, tachycardia & palpitations. These advanced to hallucinations, fever, severe weakness (unable to walk) & hypoxia.
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Induration, Influenza virus test negative, Injection site erythema, Myalgia
Clinical narrative: Pt reports expierencing night sweats, mylagia, rigors and chills about 12 hours after vaccination.   This continued for 3 more days.  With Left arm vaccination site hot to touch red and swollen and stiff with induration of 3 to 4 inches above and below vaccination site.  Pt went to see private Doctor where rapid flu test was negative.
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Night sweats, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Pt reports expierencing night sweats, mylagia, rigors and chills about 12 hours after vaccination.   This continued for 3 more days.  With Left arm vaccination site hot to touch red and swollen and stiff with induration of 3 to 4 inches above and below vaccination site.  Pt went to see private Doctor where rapid flu test was negative.
Age: 34.0
Sex: F
Vaccine: UNK
Symptoms: Blood glucose increased, Blood pressure increased, Burning sensation, Chills, Depression
Clinical narrative: INCREASED BLOOD GLUCOSE, BURNING SENSATION, DIZZINESS, HEART RATE INCREASED, DEPRESSION, INCREASED BLOOD PRESSURE, INCREASED HEART RATE, DRY MOUTH, MUSCLE SPASMS, CHILLS, DIABETIC NEUROPATHY.
Age: 34.0
Sex: F
Vaccine: UNK
Symptoms: Diabetic neuropathy, Dizziness, Dry mouth, Electrocardiogram, Full blood count
Clinical narrative: INCREASED BLOOD GLUCOSE, BURNING SENSATION, DIZZINESS, HEART RATE INCREASED, DEPRESSION, INCREASED BLOOD PRESSURE, INCREASED HEART RATE, DRY MOUTH, MUSCLE SPASMS, CHILLS, DIABETIC NEUROPATHY.
Age: 34.0
Sex: F
Vaccine: UNK
Symptoms: Heart rate increased, Muscle spasms, Ultrasound abdomen, X-ray
Clinical narrative: INCREASED BLOOD GLUCOSE, BURNING SENSATION, DIZZINESS, HEART RATE INCREASED, DEPRESSION, INCREASED BLOOD PRESSURE, INCREASED HEART RATE, DRY MOUTH, MUSCLE SPASMS, CHILLS, DIABETIC NEUROPATHY.
Age: 6.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pyrexia
Clinical narrative: Onset of fever 24 hrs post vaccine. Circular Erythema 9.25cm X 9.25cm noted on 2/1/14 at office visit.
Age: 41.0
Sex: M
Vaccine: DTAP
Symptoms: Feeling hot, Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen, painful, hot lymph node in under arm given shot.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Acoustic stimulation tests, Blood test, Computerised tomogram, Deafness unilateral, Dysgeusia
Clinical narrative: Extreme headache, pressure in head, total loss of hearing, right ear, partial hearing loss left ear, sense of taste and smell, loss of feeling on right side of head. ENT physician visit, ER visit, meds, Valtrex, Prednisone orally, steroid placed in right ear after no effect with oral meds. Left hospital AMA after told I did not have a stroke. NO! They did not like it, but I was trying to save money that I did not have! I wish that I had stayed--hind sight!
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Hypoacusis, Hypoaesthesia, Nuclear magnetic resonance imaging, Parosmia
Clinical narrative: Extreme headache, pressure in head, total loss of hearing, right ear, partial hearing loss left ear, sense of taste and smell, loss of feeling on right side of head. ENT physician visit, ER visit, meds, Valtrex, Prednisone orally, steroid placed in right ear after no effect with oral meds. Left hospital AMA after told I did not have a stroke. NO! They did not like it, but I was trying to save money that I did not have! I wish that I had stayed--hind sight!
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Sensory loss, X-ray
Clinical narrative: Extreme headache, pressure in head, total loss of hearing, right ear, partial hearing loss left ear, sense of taste and smell, loss of feeling on right side of head. ENT physician visit, ER visit, meds, Valtrex, Prednisone orally, steroid placed in right ear after no effect with oral meds. Left hospital AMA after told I did not have a stroke. NO! They did not like it, but I was trying to save money that I did not have! I wish that I had stayed--hind sight!
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Feeling hot, Swelling, Tenderness
Clinical narrative: Swelling near injection site along with redness.  No pain but warm and tender to the touch.  Still had normal range of motion and had no difficulty performing everyday activities.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Blood pressure decreased, Feeling hot, Flushing, Heart rate decreased
Clinical narrative: Pt was given PPD and HPV vaccine.  Within 15 minutes, she reported some lh.  Pt was observed and then d/ced.  She was waiting in waiting room and 30 minutes after, she complained for feeling flushed, hot, abdominal pain.  Vitals were obtained.  Pt initially with bp of 115/68, HR 93 prior to procedure.  After, it was 88/62, HR 46.  She then began to complain of throat tightness and tingling. Epinephrine administered, with bp 90/59, HR 63 and pt elected to go to ED via private vehicle.